Back to resultsA Study to Assess the Safety, Tolerability and Pharmacokinetics of TCMCB07 in Single and Multiple Ascending Doses in Health Subjects
Primary Purpose
Cachexia
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TCMCB07
TCMCB07 Matching Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cachexia
Eligibility Criteria
Inclusion Criteria:
- Healthy males and females (WONCBP), aged 18 to 55 years inclusive, at time of signing informed consent.
- Body mass index 18.0 to 30.0 kg/m2 as measured at Screening or, if outside this range, considered not clinically significant by the investigator.
- Weight ≥ 50 kg at Screening
Exclusion Criteria:
- Serious adverse reaction or serious known hypersensitivity to melanocortins or polyethylene glycol.
- Evidence of current severe acute respiratory syndrome coronavirus 2 infection.
- Clinically significant abnormal clinical chemistry, hematology, or urinalysis as judged by the investigator.
- Subjects who have received any IP in a clinical research study within 5 half-lives or within 30 days prior to first dose. However, in no event shall the time between last receipt of IP and first dose be less than 30 days.
Sites / Locations
- Quotient Sciences -- Miami, Inc.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TCMCB07
TCMCB07 Matching Placebo
Arm Description
once daily subcutaneous injection
once daily subcutaneous injection
Outcomes
Primary Outcome Measures
Number of people with an Adverse Event Assessment
Adverse Event monitoring
Number of participants with abnormal vital signs
Assessment of vital signs
Number of people with abnormal laboratory test results
Analysis of clinical chemistry, hematology, and urinalysis
Number of people with abnormal Electrocardiograms
12-lead ECGs will be used and an assessment of any clinically significant abnormality from baseline will be reported as an AE
Number of people with abnormal physical examinations
Physical and injection site examination
Secondary Outcome Measures
Peak Plasma Concentration (Cmax)
Non-compartmental techniques will be employed to obtain estimates of cmax
Area under the plasma concentration versus time curve (AUC)
Non-compartmental techniques will be employed to obtain estimates of AUC
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05529849
Brief Title
A Study to Assess the Safety, Tolerability and Pharmacokinetics of TCMCB07 in Single and Multiple Ascending Doses in Health Subjects
Official Title
A Two-Part Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Subcutaneous Doses of TCMCB07 on Healthy Male and Female Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2022 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
January 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endevica Bio
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study will test an experimental drug named TCMCB07 for the treatment of cancer cachexia. Cachexia is a syndrome characterized by weight loss, anorexia, weakness or lack of energy, and anemia. Cachexia occurs in many cancers, usually at the advanced stages of disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cachexia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
97 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TCMCB07
Arm Type
Experimental
Arm Description
once daily subcutaneous injection
Arm Title
TCMCB07 Matching Placebo
Arm Type
Placebo Comparator
Arm Description
once daily subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
TCMCB07
Intervention Description
Subcutaneous injection of TCMCB07
Intervention Type
Drug
Intervention Name(s)
TCMCB07 Matching Placebo
Intervention Description
Matching subcutaneous placebo
Primary Outcome Measure Information:
Title
Number of people with an Adverse Event Assessment
Description
Adverse Event monitoring
Time Frame
6 Months
Title
Number of participants with abnormal vital signs
Description
Assessment of vital signs
Time Frame
6 Months
Title
Number of people with abnormal laboratory test results
Description
Analysis of clinical chemistry, hematology, and urinalysis
Time Frame
6 Months
Title
Number of people with abnormal Electrocardiograms
Description
12-lead ECGs will be used and an assessment of any clinically significant abnormality from baseline will be reported as an AE
Time Frame
6 Months
Title
Number of people with abnormal physical examinations
Description
Physical and injection site examination
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Peak Plasma Concentration (Cmax)
Description
Non-compartmental techniques will be employed to obtain estimates of cmax
Time Frame
6 Months
Title
Area under the plasma concentration versus time curve (AUC)
Description
Non-compartmental techniques will be employed to obtain estimates of AUC
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy males and females (WONCBP), aged 18 to 55 years inclusive, at time of signing informed consent.
Body mass index 18.0 to 30.0 kg/m2 as measured at Screening or, if outside this range, considered not clinically significant by the investigator.
Weight ≥ 50 kg at Screening
Exclusion Criteria:
Serious adverse reaction or serious known hypersensitivity to melanocortins or polyethylene glycol.
Evidence of current severe acute respiratory syndrome coronavirus 2 infection.
Clinically significant abnormal clinical chemistry, hematology, or urinalysis as judged by the investigator.
Subjects who have received any IP in a clinical research study within 5 half-lives or within 30 days prior to first dose. However, in no event shall the time between last receipt of IP and first dose be less than 30 days.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chief Commercialization Officer
Phone
573-881-5080
Email
info@endevicabio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Bermudez, MD, CPI
Organizational Affiliation
Quotient Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quotient Sciences -- Miami, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suhaills Perez-Carrillo
Phone
305-644-9903
Ext
149
Email
Suhaills.Perez-Carrillo@quotientsciences.com
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.endevicabio.com
Description
Related Info
Learn more about this trial
A Study to Assess the Safety, Tolerability and Pharmacokinetics of TCMCB07 in Single and Multiple Ascending Doses in Health Subjects
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