A Study to Assess the Safety, Tolerability and Pharmacokinetics of TCMCB07 in Single and Multiple Ascending Doses in Health Subjects

Phase 1

Completed

• Conditions: Cachexia
• Interventions: Drug: TCMCB07; Drug: Placebo

• Registration Number: NCT05529849
• Lead Sponsor: Endevica Bio

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-12
• Study First Submitted: 2022-07-28
• Study First Submitted QC: 2022-09-02
• Study First Posted: 2022-09-07
• Primary Completion: 2022-12-12
• Study Completion: 2023-02-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TCMCB07	TCMCB07	once daily subcutaneous injection
Placebo	Placebo	once daily subcutaneous injection

Primary Outcome Measures

Name	Time	Method
Number of people with an Adverse Event Assessment	6 Months	Adverse Event monitoring
Number of people with abnormal physical examinations	6 Months	Physical and injection site examination
Number of participants with abnormal vital signs	6 Months	Assessment of vital signs
Number of people with abnormal Electrocardiograms	6 Months	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 laboratory test results	6 Months	Analysis of clinical chemistry, hematology, and urinalysis

Secondary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC)	6 months	Non-compartmental techniques will be employed to obtain estimates of AUC
Peak Plasma Concentration (Cmax)	6 Months	Non-compartmental techniques will be employed to obtain estimates of cmax

Trial Locations

Locations (1)

Quotient Sciences -- Miami, Inc.; 🇺🇸 Miami, Florida, United States