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Study to Assess PDM608 in Healthy Adult Subjects

Primary Purpose

Parkinson Disease

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PDM608

Placebo

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy men, or women of non-childbearing potential Must agree to use an adequate method of contraception Body mass index (BMI) of 18.0 to 33.0 kg/m2 as measured at screening Exclusion Criteria: Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients Significant allergy requiring treatment History of clinically significant autoimmune, cardiovascular, renal, hepatic, chronic respiratory or GI disease (except cholecystectomy), neurological or psychiatric disorder, illness/infection/hospitalization or surgical procedure within 30 days prior to first dose of study drug or any uncontrolled medical illness as judged by the investigator Have poor venous access that limits phlebotomy Evidence of current SARS-CoV-2 infection or exposure to confirmed infection within 10 days prior to the first dose of study drug Clinically significant abnormal clinical chemistry, hematology or urinalysis Hepatitis B, Hepatitis C, HIV, TB Renal impairment Pregnant or lactating women or men with pregnant or lactating partners Received any IMP in a clinical research study within 5 half-lives or within 30 days prior to first dose (whichever is longer) Taking any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g per day acetaminophen and HRT) in the 14 days or 5 half-lives (whichever is longer) before IMP administration COVID-19 vaccine within 14 days prior to first dose or have a COVID-19 vaccine scheduled between their first dose of IMP and last dose of IMP. Drug or alcohol abuse in the past 2 years Regular alcohol consumption in men >21 units per week and women >14 units per week (1 unit = 12 oz 1 bottle/can of beer, 1 oz 40% spirit or 5 oz glass of wine) Positive alcohol urine test at screening or first admission Current and within the last six months-smokers, e-cigarettes and nicotine replacement users Donation of blood within 2 months or donation of plasma within 7 days prior to first dose of study medication Subjects who are, or are immediate family members of, a study site or Sponsor employee

Sites / Locations

Quotient Sciences-Miami, IncRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Part 1 SAD SC PDM608

Part 1 SAD SC Placebo

Part 2 MAD SC PDM608

Part 2 MAD SC Placebo

Arm Description

Single ascending dose, subcutaneous administration of PDM608

Single ascending dose, subcutaneous administration of matching placebo

Multiple ascending dose, subcutaneous administration of PDM608 once weekly for 4 weeks.

Multiple ascending dose, subcutaneous administration of placebo once weekly for 4 weeks.

Outcomes

Primary Outcome Measures

Number of participants with adverse events

Adverse events will be analyzed for severity and potential relationship to PDM608 to determine safety and tolerability of PDM608

Number of participants with clinically significant abnormal laboratory test results

Results outside of laboratory defined normal ranges will be analyzed for clinical significance and used to determine safety and tolerability of PDM608

Number of participants with abnormal electrocardiogram readings: QTcF

Abnormal QTcF interval

Number of participants with abnormal electrocardiogram readings: VR

Abnormal ventricular rate

Number of participants with abnormal electrocardiogram readings: PR interval

Abnormal PR interval

Number of participants with abnormal electrocardiogram readings: QRS duration

Abnormal QRS duration

Number of participants with abnormal electrocardiogram readings: QRS axis

Abnormal QRS axis

Number of participants with abnormal vital signs: BP

Abnormal systolic and/or diastolic pressure (mmHg)

Number of participants with abnormal vital signs: HR

Abnormal heart rate (beats/minute)

Number of participants with abnormal vital signs: Temp

Abnormal body temperature (Celsius)

Number of participants with abnormal vital signs: RR

Abnormal respiratory rate (breaths/minute)

Number of participants with abnormal physical exams

Physical exams will include evaluation of general appearance, head, neck, thyroid, eyes, ears, nose and throat, respiratory, cardiovascular, abdomen, dermatological, genitourinary, musculoskeletal and neurological systems

Assess PK parameters for single (Part 1) and multiple (Part 2) SC doses of PDM608 in healthy volunteers.

Analysis of PDM608 plasma concentration data will be performed using PK parameters.

Secondary Outcome Measures

To assess immunogenicity following single and multiple doses of PDM608

Incidence of ADA in blood

Full Information

NCT ID

NCT05950906

First Posted

May 22, 2023

Last Updated

July 17, 2023

Sponsor

Calibr, a division of Scripps Research

Collaborators

Michael J. Fox Foundation for Parkinson's Research, Alzheimer's Drug Discovery Foundation

1. Study Identification

Unique Protocol Identification Number

NCT05950906

Brief Title

Study to Assess PDM608 in Healthy Adult Subjects

Official Title

A Two-Part Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of PDM608 in Healthy Adult Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 27, 2023 (Actual)

Primary Completion Date

March 26, 2024 (Anticipated)

Study Completion Date

April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Calibr, a division of Scripps Research

Collaborators

Michael J. Fox Foundation for Parkinson's Research, Alzheimer's Drug Discovery Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of PDM608 in healthy adult subjects.

Detailed Description

This is a 2-part, single-center, first-in-human study of single ascending doses (SAD; Part 1) and multiple ascending doses (MAD; Part 2) of PDM608 in healthy adult subjects. Part 1 is a double-blind, randomized, placebo-controlled assessment of subcutaneous (SC) SAD administrations of PDM608 across 5 cohorts of subjects. All SAD cohorts will follow a sentinel design. Following completion of each cohort, safety and tolerability data through 96 hours post-dose will be reviewed to determine whether to progress to the next dose level and the dose level for the next cohort. Part 2 is a double-blind, randomized, placebo-controlled assessment of SC MAD administrations (once weekly for 4 weeks) of PDM608 across up to 4 cohorts of subjects. Following completion of each cohort the safety and tolerability data 96 hours post last dose will be reviewed to determine whether to progress to the next dose level and the dose level to be administered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Part 1 Cohorts 1-5 will assess single ascending doses (SAD) of subcutaneous administration PDM608. Part 2 will assess multiple ascending doses (MAD) administrations given once weekly for 4 weeks in up to 4 cohorts of participants. The parts of the study are not required to be conducted entirely sequentially, provided that this is justified by PK and safety data obtained from completed cohorts. The first MAD cohort will not start until data are available from SAD Cohort 3 and dosing for each MAD cohort will not exceed the a dose level previously deemed safe in a SAD cohort.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

This is a double-blind study; treatment assignment will not be known to the subjects, the Sponsor and staff involved in the clinical evaluation of the subjects and the analysis of data. The randomization schedule and disclosure envelopes will be generated by an unblinded statistician. The unblinded statistician will not be involved in decisions relating to populations for analysis prior to unblinding. Prior to database lock and unblinding, all original randomization materials including the original final signed and dated randomization schedule will be held by the Quality Assurance department at the study site. The Data Sciences department will not have access to the randomization schedule before database lock/unblinding. There may be instances where interim data has the potential to reveal treatment. In these cases, every effort will be made by the unblinded pharmacokinetic scientist to maintain blinding by appropriate presentation of data to the study team.

Allocation

Randomized

Enrollment

88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Part 1 SAD SC PDM608

Arm Type

Experimental

Arm Description

Single ascending dose, subcutaneous administration of PDM608

Arm Title

Part 1 SAD SC Placebo

Arm Type

Placebo Comparator

Arm Description

Single ascending dose, subcutaneous administration of matching placebo

Arm Title

Part 2 MAD SC PDM608

Arm Type

Experimental

Arm Description

Multiple ascending dose, subcutaneous administration of PDM608 once weekly for 4 weeks.

Arm Title

Part 2 MAD SC Placebo

Arm Type

Placebo Comparator

Arm Description

Multiple ascending dose, subcutaneous administration of placebo once weekly for 4 weeks.

Intervention Type

Drug

Intervention Name(s)

PDM608

Intervention Description

PDM608 subcutaneous at single or multiple dose(s) assigned by cohort

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo subcutaneous at single or multiple dose(s) to match PDM608 administration.

Primary Outcome Measure Information:

Title

Number of participants with adverse events

Description

Adverse events will be analyzed for severity and potential relationship to PDM608 to determine safety and tolerability of PDM608

Time Frame