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Evaluation of Efficacy, Tolerability, and Pharmacokinetics of MYMD1 for Chronic Inflammation and Sarcopenia/Frailty

Primary Purpose

Sarcopenia, Frailty, Aging

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MYMD-1 600MG
MYMD-1 750mg
MYMD-1 900mg
MYMD-1 1050mg
placebo 600mg
placebo 750mg
placebo 900mg
placebo 1050mg
Sponsored by
MyMD Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring frailty, aging, sarcopenia

Eligibility Criteria

65 Years - 99 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged 65 years or older, at the time of signing the ICF

    Type of Participant and Disease Characteristics

  2. Elevated biomarkers of inflammation (serum IL-6 level ≥2.5 pg/mL and/or sTNFR1 level ≥1500 pg/mL)
  3. Low gait speed ≤ 0.8 m/s
  4. Short Physical Performance Battery (SPPB) score ≤8

    Weight

  5. Body weight ≥35 kg Other
  6. Adequate dietary intake
  7. Able to complete a 4-meter timed walk
  8. Assessment and documentation of sarcopenia-related loss of muscle mass based on Dual-energy X-ray absorptiometry (DXA) -derived appendicular skeletal muscle mass index (ASMI) measurements.

    Reproductive Status

  9. Male participants who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
  10. Female participants are eligible to participate if they do not qualify as a woman of childbearing potential (WOCBP)

    Informed Consent

  11. Capable of giving signed informed consent as described in Appendix 2, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol

Exclusion Criteria:

  1. Taking anti-inflammatory drugs on a daily basis. Note: If the participant has been stable on their antidepressant regimen for at least 3 months and agrees not to increase the medicine for the 28 days of treatment in the trial, they may be allowed into the study
  2. Currently tobacco users or those who used tobacco within 30 days of study entry
  3. Dementia, encephalopathy or any medical condition impacting cognition
  4. Medical conditions that would impact mobility testing or handgrip strength including
  5. Rheumatoid arthritis, any autoimmune condition, Parkinson's disease, muscular dystrophy, cerebral vascular accident, lower or upper extremity neuropathy, major skeletal joint deformity, upper extremity joint dysfunction, partial or complete upper extremity amputation or missing anatomy impacting grip, history of pain with walking, gout, chronic obstructive pulmonary disease, congestive heart failure, exercise induced angina, lower extremity amputation (partial or complete) or missing anatomy impacting walking, recent surgery or hospitalization (past 3 months); lower or upper extremity fracture in the past 6 months, lower or upper extremity tendinitis, diagnosis of cancer other than basal cell carcinoma, dialysis dependent renal disease, Meniere's disease, spinal cord fracture or compression, paraplegia or quadriplegia or any other medical condition that in the opinion of the Investigator would impair measurement of a 6-minute walk or handgrip strength
  6. A lower limb fracture in the past 6 months or any impairment or disease severely affecting gait (eg, stroke with hemiparesis, myasthenia gravis, Parkinson's disease, peripheral polyneuropathy, intermittent claudication in advanced peripheral vascular disease, spinal stenosis, or severe osteoarthritis of the knee or hip with ineffective pain management)
  7. Requires regular assistance from another person for general activities of daily living (eg, bathing, dressing, toileting)
  8. History of cardiac conduction abnormalities, arrhythmias, and/or bradycardia
  9. Intraocular surgery and laser procedures for refractive correction within 6 months prior to screening
  10. Any underlying muscle disease including active myopathy or muscular dystrophy
  11. Confirmed diagnosis of heart failure classified as New York Heart Association Class III or IV (eg, dilated cardiomyopathy)
  12. Type I diabetes or uncontrolled Type 2 diabetes
  13. Chronic kidney disease (estimated glomerular filtration rate [eGFR] <60 mL/min)
  14. History of confirmed chronic obstructive pulmonary disease with a severity Grade >2 on the Medical Research Council Dyspnea Scale
  15. Confirmed rheumatoid arthritis or other systemic autoimmune disease requiring immunosuppressive therapy or corticosteroids >10 mg/day prednisone equivalent
  16. Known history or presence of severe active acute or chronic liver disease (eg, cirrhosis)
  17. Myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention (eg, angioplasty or stent placement), or deep vein thrombosis/pulmonary embolism within 12 weeks of screening
  18. Active cancer (ie, under current treatment), or cancer requiring treatment in the last 5 years excluding non-melanoma skin cancers or cancers with excellent prognosis (eg, early-stage prostate or breast cancer, carcinoma in situ of the uterine cervix)
  19. Any known chronic active infection
  20. Use of any anxiolytics, cannabis or opioid medications
  21. Currently abusing drugs or alcohol, and/or have a history of drug or alcohol dependence within 6 months of entering this study
  22. A score of <23 on the Mini Mental Status Exam
  23. Treatment with any prescription or investigational drugs, devices or chemotherapy, or any other therapies for sarcopenia
  24. Use of medications with narrow therapeutic ranges within 48 hours of the first dose of study treatment
  25. Current use of systemic steroids or use of systemic steroids within 90 days of treatment except for prophylaxis against imaging contrast dye allergy or replacement-dose steroids in the setting of adrenal insufficiency (providing this is ≤10 mg/day prednisone or equivalent; see Appendix 5 for steroid conversion table), or transient exacerbations of other underlying diseases such as chronic obstructive pulmonary disease requiring treatment for <3 weeks
  26. Vaccination with live vaccines while on study

Sites / Locations

  • Clinical Research of West Florida, IncRecruiting
  • Clinical Research of West FloridaRecruiting
  • Johns Hopkins Bayview Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Cohort 1: MYMD1 600mg

Cohort 1: Placebo 600mg

Cohort 2: MYMD1 750mg

Cohort 2: Placebo 750mg

Cohort 3: MYMD1 900mg

Cohort 3: Placebo 900mg

Cohort 4: MYMD1 1050mg

Cohort 4: Placebo group 1050mg

Arm Description

Subjects randomly assigned to the MYMD1 600mg cohort

Subjects assigned to the 600mg placebo group

Subjects randomly assigned to the MYMD1 750 cohort

Subjects assigned to the 750mg placebo group

Subjects randomly assigned to the MYMD1 900mg cohort

Subjects assigned to the 900mg placebo group

Subjects randomly assigned to the MYMD1 1050mg cohort

Subjects assigned to the 1050mg placebo group

Outcomes

Primary Outcome Measures

Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1
Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment
Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1
Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment
Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1
Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment
Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1
Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment
Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1
Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment
Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1
Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment
To evaluate the PK of oral doses of MYMD1 capsules
Area Under the Curve (AUC) (0-last): variation of a drug concentration in blood plasma as a function of time, compared across treatment and placebo groups.
To evaluate the PK of oral doses of MYMD1 capsules
Pharmacokinetics: Cmax - Maximum Concentration of drug substance in blood plasma, compared across treatment and placebo groups.
To evaluate the PK of oral doses of MYMD1 capsules
Pharmacokintetics: tmax - Time to Maximum Concentration of drug substance in blood plasma, compared across treatment and placebo groups.
To evaluate the PK of oral doses of MYMD1 capsules
Pharmacokinetics: t1/2 - Time to metabolize 1/2 of dose (eg, half-life) of drug substance, measured in blood plasma, compared across treatment and placebo groups.
To evaluate the PK of oral doses of MYMD1 capsules
Pharmacokinetics: CL/F - Oral Clearance of the drug substance (CL/F), compared across treatment and placebo groups.
To evaluate the PK of oral doses of MYMD1 capsules
Pharmacokinetics: Volume of Distribution (V2/F ) - Volume of Distribution of the drug substance (V2/F), compared across treatment and placebo groups.
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1
To evaluate the PK (urine) of oral doses of MYMD1 capsules
urine sample collection for presence of parent drug - MYMD1

Secondary Outcome Measures

Incidence of Treatment-Emergent Adverse Events
Safety and Tolerability

Full Information

First Posted
February 16, 2022
Last Updated
March 24, 2023
Sponsor
MyMD Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05283486
Brief Title
Evaluation of Efficacy, Tolerability, and Pharmacokinetics of MYMD1 for Chronic Inflammation and Sarcopenia/Frailty
Official Title
A Double-blind, Randomized, Phase 2 Study to Investigate the Efficacy, Tolerability and Pharmacokinetics of MYMD1 in the Treatment of Participants Aged 65 Years or Older With Chronic Inflammation Associated With Sarcopenia/Frailty
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
May 10, 2023 (Anticipated)
Study Completion Date
June 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MyMD Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study will be conducted to investigate the efficacy, tolerability and pharmacokinetics of MYMD1 in participants with chronic inflammation associated with sarcopenia/frailty, a condition linked to elevated levels of proinflammatory cytokines.
Detailed Description
This is a double-blind, placebo-controlled evaluation of the efficacy, tolerability and pharmacokinetics (PK), of MYMD1 in participants aged 65 years or older with chronic inflammation associated with sarcopenia/frailty. After participants sign the informed consent form (ICF), they will enter the screening period which will not exceed 28 days. Participants who fulfill all the inclusion criteria and none of the exclusion criteria will be randomized (4:1) to receive MYMD1 or placebo in a blinded fashion until the end of-study (EOS) visit on Day 28. A participant is considered to have completed the study if he/she has completed all phases of the study including the EOS visit scheduled on Day 28. Follow up: Participants will be contacted within 24 hours post Day 1 treatment for routine medical assessment. Participants will be contacted by phone every two days post discharge until day 7 visit. Week two post discharge participants will be instructed to call the Clinical nurse and/or the 24-hour medical monitor for any study related concerns. After the EOS visit, participants will be contacted by phone weekly for a completed 30 day follow up and documented close out. Study treatment will be dispensed on Day 1 of each cohort. Cohort 1 will be required to take 600mg [4 capsules of 150 mg each or matching placebo]; Cohort 2 will be required to take 750mg ([5 capsules of 150 mg each or matching placebo]; Cohort 3 will be required to take 900mg ([6 capsules of 150 mg each or matching placebo]; and Cohort 4 will be required to take 1050mg ([7 capsules of 150 mg each or matching placebo] orally each orally each day throughout the treatment duration. On Day 1, a single, oral dose of MYMD1 or placebo will be administered following an overnight fast of at least 12 hours. The participants may have applesauce, 15 to 20 minutes post dose. Number of Investigators and Study Centers: Approximately 2 sites are expected to participate in this study. Number of Participants: Approximately 40 participants will be enrolled in this study; 32 participants will receive the study treatment (MYMD1) and 8 will receive the placebo. Treatment Groups and Duration: The overall duration for all participants enrolled in this study will be 28 days. Serial PK sampling will be collected across all cohorts. Statistical methods: Incidence of adverse events will be summarized by dose level, by preferred term, and by severity and relationship to the study treatment. Descriptive statistics will be tabulated for clinical laboratory tests, electrocardiogram intervals, and vital signs. MYMD1 concentrations and calculated PK parameters will be summarized by dose level and study data. Dose proportionality of MYMD1 will be explored graphically, and if appropriate, by using a regression model. Pyridyloxobutyl and tumor necrosis factor-α results and corresponding changes from baseline will be summarized by dose level. Individual participant data will be presented in listings. For change from baseline efficacy analyses, only participants with a baseline and at least one non missing postbaseline measurement will be included. Treatment emergent Adverse Eventss (TEAEs) by maximum severity, TEAEs by relationship to study treatment, Serious Adverse Events, TEAEs leading to death, and TEAEs leading to discontinuation of study treatment will be tabulated for each treatment group. Commonly occurring TEAEs in either treatment group, will be summarized using descriptive statistics. All laboratory test results, vital signs measurements, electrocardiogram (ECG) results, and weight will be summarized for each treatment group using descriptive statistics at each visit for raw numbers and change from baseline. The incidence of treatment emergent abnormal laboratory values, vital signs, neurological exam and ECG values will also be summarized using descriptive statistics. Safety Review Committee A Safety Review Committee (SRC) consisting of the Investigator, Medical Monitor, and PK Scientist will review the available PK safety data to decide whether to escalate to the next higher planned dose, to repeat a dose level or to stop the dose escalation. To maintain the treatment assignment blinded, safety data will exclude treatment assignment and PK data will have blinded participant identification numbers. All SRC decisions, along with their rationale, will be documented in writing, and retained in the study files. The data review and analysis will be based on the available Investigator-reported data in the clinical database at that time. Data to be reviewed will include safety, tolerability, and available PK data through day 8. The Coordinating Investigator and the Sponsor, when appropriate, will invite other specialist individuals to participate in the review, eg, PK scientists, statisticians, and clinical specialists. MyMD Pharmaceuticals, Inc. will also have a board-certified cardiologist and neurologist available for consultation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Frailty, Aging
Keywords
frailty, aging, sarcopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
This is a double-blind clinical trial.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: MYMD1 600mg
Arm Type
Experimental
Arm Description
Subjects randomly assigned to the MYMD1 600mg cohort
Arm Title
Cohort 1: Placebo 600mg
Arm Type
Placebo Comparator
Arm Description
Subjects assigned to the 600mg placebo group
Arm Title
Cohort 2: MYMD1 750mg
Arm Type
Experimental
Arm Description
Subjects randomly assigned to the MYMD1 750 cohort
Arm Title
Cohort 2: Placebo 750mg
Arm Type
Placebo Comparator
Arm Description
Subjects assigned to the 750mg placebo group
Arm Title
Cohort 3: MYMD1 900mg
Arm Type
Experimental
Arm Description
Subjects randomly assigned to the MYMD1 900mg cohort
Arm Title
Cohort 3: Placebo 900mg
Arm Type
Placebo Comparator
Arm Description
Subjects assigned to the 900mg placebo group
Arm Title
Cohort 4: MYMD1 1050mg
Arm Type
Active Comparator
Arm Description
Subjects randomly assigned to the MYMD1 1050mg cohort
Arm Title
Cohort 4: Placebo group 1050mg
Arm Type
Placebo Comparator
Arm Description
Subjects assigned to the 1050mg placebo group
Intervention Type
Drug
Intervention Name(s)
MYMD-1 600MG
Other Intervention Name(s)
MYMD1 600mg
Intervention Description
Cohort 1: 600mg drug
Intervention Type
Drug
Intervention Name(s)
MYMD-1 750mg
Other Intervention Name(s)
MYMD1 750mg
Intervention Description
Cohort 2: 750mg drug
Intervention Type
Drug
Intervention Name(s)
MYMD-1 900mg
Other Intervention Name(s)
MYMD1 900mg
Intervention Description
Cohort 3: 900mg drug
Intervention Type
Drug
Intervention Name(s)
MYMD-1 1050mg
Other Intervention Name(s)
MYMD1 1050mg
Intervention Description
Cohort 4: 1050mg drug
Intervention Type
Drug
Intervention Name(s)
placebo 600mg
Other Intervention Name(s)
placebo-600mg
Intervention Description
Cohort 1: 600mg placebo
Intervention Type
Drug
Intervention Name(s)
placebo 750mg
Other Intervention Name(s)
placebo-750mg
Intervention Description
Cohort 2: 750mg placebo
Intervention Type
Drug
Intervention Name(s)
placebo 900mg
Other Intervention Name(s)
placebo-900mg
Intervention Description
Cohort 3: 900mg placebo
Intervention Type
Drug
Intervention Name(s)
placebo 1050mg
Other Intervention Name(s)
placebo-1050mg
Intervention Description
Cohort 4: 1050mg placebo
Primary Outcome Measure Information:
Title
Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1
Description
Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment
Time Frame
Screening
Title
Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1
Description
Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment
Time Frame
Day 1
Title
Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1
Description
Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment
Time Frame
Day 7
Title
Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1
Description
Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment
Time Frame
Day 14
Title
Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1
Description
Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment
Time Frame
Day 21
Title
Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1
Description
Effect on serum levels of sTNFR1, IL-6, and TNFα over 28 days of treatment
Time Frame
Day 28
Title
To evaluate the PK of oral doses of MYMD1 capsules
Description
Area Under the Curve (AUC) (0-last): variation of a drug concentration in blood plasma as a function of time, compared across treatment and placebo groups.
Time Frame
Cohorts 1, 2, 3, 4: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24 hrs; Day 7, pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24; Day 14, pre-dose, 0.5 hrs; Day 21, pre-dose, 0.5 hrs; Day 28, pre-dose, 0.5 hrs]
Title
To evaluate the PK of oral doses of MYMD1 capsules
Description
Pharmacokinetics: Cmax - Maximum Concentration of drug substance in blood plasma, compared across treatment and placebo groups.
Time Frame
Cohorts 1, 2, 3, 4: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24 hrs; Day 7, pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24; Day 14, pre-dose, 0.5 hrs; Day 21, pre-dose, 0.5 hrs; Day 28, pre-dose, 0.5 hrs]
Title
To evaluate the PK of oral doses of MYMD1 capsules
Description
Pharmacokintetics: tmax - Time to Maximum Concentration of drug substance in blood plasma, compared across treatment and placebo groups.
Time Frame
Cohorts 1, 2, 3, 4: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24 hrs; Day 7, pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24; Day 14, pre-dose, 0.5 hrs; Day 21, pre-dose, 0.5 hrs; Day 28, pre-dose, 0.5 hrs]
Title
To evaluate the PK of oral doses of MYMD1 capsules
Description
Pharmacokinetics: t1/2 - Time to metabolize 1/2 of dose (eg, half-life) of drug substance, measured in blood plasma, compared across treatment and placebo groups.
Time Frame
Cohorts 1, 2, 3, 4: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24 hrs; Day 7, pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24; Day 14, pre-dose, 0.5 hrs; Day 21, pre-dose, 0.5 hrs; Day 28, pre-dose, 0.5 hrs]
Title
To evaluate the PK of oral doses of MYMD1 capsules
Description
Pharmacokinetics: CL/F - Oral Clearance of the drug substance (CL/F), compared across treatment and placebo groups.
Time Frame
Cohorts 1, 2, 3, 4: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24 hrs; Day 7, pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24; Day 14, pre-dose, 0.5 hrs; Day 21, pre-dose, 0.5 hrs; Day 28, pre-dose, 0.5 hrs]
Title
To evaluate the PK of oral doses of MYMD1 capsules
Description
Pharmacokinetics: Volume of Distribution (V2/F ) - Volume of Distribution of the drug substance (V2/F), compared across treatment and placebo groups.
Time Frame
Cohorts 1, 2, 3, 4: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24 hrs; Day 7, pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 24; Day 14, pre-dose, 0.5 hrs; Day 21, pre-dose, 0.5 hrs; Day 28, pre-dose, 0.5 hrs]
Title
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Description
urine sample collection for presence of parent drug - MYMD1
Time Frame
Day 1 (predose)
Title
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Description
urine sample collection for presence of parent drug - MYMD1
Time Frame
Day 1 (0-4 hrs post dose)
Title
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Description
urine sample collection for presence of parent drug - MYMD1
Time Frame
Day 1 (4-8 hrs post dose)
Title
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Description
urine sample collection for presence of parent drug - MYMD1
Time Frame
Day 1(8-24hrs post dose)
Title
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Description
urine sample collection for presence of parent drug - MYMD1
Time Frame
Day 7 (predose)
Title
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Description
urine sample collection for presence of parent drug - MYMD1
Time Frame
Day 7 (0-4 hours post dose)
Title
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Description
urine sample collection for presence of parent drug - MYMD1
Time Frame
Day 7 (4-8 hours post dose)
Title
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Description
urine sample collection for presence of parent drug - MYMD1
Time Frame
Day 7 (8-24hrs post dose)
Title
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Description
urine sample collection for presence of parent drug - MYMD1
Time Frame
Day 14 (predose)
Title
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Description
urine sample collection for presence of parent drug - MYMD1
Time Frame
Day 14 (0-4 hours post dose)
Title
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Description
urine sample collection for presence of parent drug - MYMD1
Time Frame
Day 14 (4-8 hours post dose)
Title
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Description
urine sample collection for presence of parent drug - MYMD1
Time Frame
Day 14 (8-24 hours post dose)
Title
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Description
urine sample collection for presence of parent drug - MYMD1
Time Frame
Day 21 (predose)
Title
To evaluate the PK of oral doses of MYMD1 capsules
Description
urine sample collection for presence of parent drug - MYMD1
Time Frame
Day 21 (0-4 hrs post dose)
Title
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Description
urine sample collection for presence of parent drug - MYMD1
Time Frame
Day 21 (4-8 hours post dose)
Title
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Description
urine sample collection for presence of parent drug - MYMD1
Time Frame
Day 21 (8-24 hours post dose)
Title
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Description
urine sample collection for presence of parent drug - MYMD1
Time Frame
Day 28 (pre dose)
Title
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Description
urine sample collection for presence of parent drug - MYMD1
Time Frame
Day 28 (0-4hours post dose)
Title
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Description
urine sample collection for presence of parent drug - MYMD1
Time Frame
Day 28 (4-8 hours post dose)
Title
To evaluate the PK (urine) of oral doses of MYMD1 capsules
Description
urine sample collection for presence of parent drug - MYMD1
Time Frame
Day 28 (8-24 hours post dose)
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
Safety and Tolerability
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 65 years or older, at the time of signing the ICF Type of Participant and Disease Characteristics Elevated biomarkers of inflammation (serum IL-6 level ≥2.5 pg/mL and/or sTNFR1 level ≥1500 pg/mL) Low gait speed ≤ 0.8 m/s Short Physical Performance Battery (SPPB) score ≤8 Weight Body weight ≥35 kg Other Adequate dietary intake Able to complete a 4-meter timed walk Assessment and documentation of sarcopenia-related loss of muscle mass based on Dual-energy X-ray absorptiometry (DXA) -derived appendicular skeletal muscle mass index (ASMI) measurements. Reproductive Status Male participants who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception Female participants are eligible to participate if they do not qualify as a woman of childbearing potential (WOCBP) Informed Consent Capable of giving signed informed consent as described in Appendix 2, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol Exclusion Criteria: Taking anti-inflammatory drugs on a daily basis. Note: If the participant has been stable on their antidepressant regimen for at least 3 months and agrees not to increase the medicine for the 28 days of treatment in the trial, they may be allowed into the study Currently tobacco users or those who used tobacco within 30 days of study entry Dementia, encephalopathy or any medical condition impacting cognition Medical conditions that would impact mobility testing or handgrip strength including Rheumatoid arthritis, any autoimmune condition, Parkinson's disease, muscular dystrophy, cerebral vascular accident, lower or upper extremity neuropathy, major skeletal joint deformity, upper extremity joint dysfunction, partial or complete upper extremity amputation or missing anatomy impacting grip, history of pain with walking, gout, chronic obstructive pulmonary disease, congestive heart failure, exercise induced angina, lower extremity amputation (partial or complete) or missing anatomy impacting walking, recent surgery or hospitalization (past 3 months); lower or upper extremity fracture in the past 6 months, lower or upper extremity tendinitis, diagnosis of cancer other than basal cell carcinoma, dialysis dependent renal disease, Meniere's disease, spinal cord fracture or compression, paraplegia or quadriplegia or any other medical condition that in the opinion of the Investigator would impair measurement of a 6-minute walk or handgrip strength A lower limb fracture in the past 6 months or any impairment or disease severely affecting gait (eg, stroke with hemiparesis, myasthenia gravis, Parkinson's disease, peripheral polyneuropathy, intermittent claudication in advanced peripheral vascular disease, spinal stenosis, or severe osteoarthritis of the knee or hip with ineffective pain management) Requires regular assistance from another person for general activities of daily living (eg, bathing, dressing, toileting) History of cardiac conduction abnormalities, arrhythmias, and/or bradycardia Intraocular surgery and laser procedures for refractive correction within 6 months prior to screening Any underlying muscle disease including active myopathy or muscular dystrophy Confirmed diagnosis of heart failure classified as New York Heart Association Class III or IV (eg, dilated cardiomyopathy) Type I diabetes or uncontrolled Type 2 diabetes Chronic kidney disease (estimated glomerular filtration rate [eGFR] <60 mL/min) History of confirmed chronic obstructive pulmonary disease with a severity Grade >2 on the Medical Research Council Dyspnea Scale Confirmed rheumatoid arthritis or other systemic autoimmune disease requiring immunosuppressive therapy or corticosteroids >10 mg/day prednisone equivalent Known history or presence of severe active acute or chronic liver disease (eg, cirrhosis) Myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention (eg, angioplasty or stent placement), or deep vein thrombosis/pulmonary embolism within 12 weeks of screening Active cancer (ie, under current treatment), or cancer requiring treatment in the last 5 years excluding non-melanoma skin cancers or cancers with excellent prognosis (eg, early-stage prostate or breast cancer, carcinoma in situ of the uterine cervix) Any known chronic active infection Use of any anxiolytics, cannabis or opioid medications Currently abusing drugs or alcohol, and/or have a history of drug or alcohol dependence within 6 months of entering this study A score of <23 on the Mini Mental Status Exam Treatment with any prescription or investigational drugs, devices or chemotherapy, or any other therapies for sarcopenia Use of medications with narrow therapeutic ranges within 48 hours of the first dose of study treatment Current use of systemic steroids or use of systemic steroids within 90 days of treatment except for prophylaxis against imaging contrast dye allergy or replacement-dose steroids in the setting of adrenal insufficiency (providing this is ≤10 mg/day prednisone or equivalent; see Appendix 5 for steroid conversion table), or transient exacerbations of other underlying diseases such as chronic obstructive pulmonary disease requiring treatment for <3 weeks Vaccination with live vaccines while on study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Director of Regulatory Affairs
Phone
(813) 864-2566
Email
jbrager@mymd.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonard Dunn, MD
Organizational Affiliation
Clinical Research of West Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lon Lynn, DO
Organizational Affiliation
Clinical Research of West Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeremy Walston, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research of West Florida, Inc
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamee Moran, MS
Phone
727-466-0078
Ext
229
Email
JMoran@crwf.com
First Name & Middle Initial & Last Name & Degree
Leonard Dunn, MD
Facility Name
Clinical Research of West Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyndall Carter
Phone
813-870-1292
Ext
130
Email
KCarter@crwf.com
First Name & Middle Initial & Last Name & Degree
Lon Lynn, DO
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jackie Langdon
Phone
410-550-2052
Email
jlangdon@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Jeremy Walston, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Efficacy, Tolerability, and Pharmacokinetics of MYMD1 for Chronic Inflammation and Sarcopenia/Frailty

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