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

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Endevica Bio

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.