A Study to Assess the Safety, Tolerability and Pharmacokinetics of TCMCB07 in Single and Multiple Ascending Doses in Health Subjects
NCT05529849 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76
Last updated 2024-02-21
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.
Conditions
- Cachexia
Interventions
- DRUG
-
TCMCB07
Subcutaneous injection of TCMCB07
- DRUG
-
Matching subcutaneous placebo
Sponsors & Collaborators
-
Endevica Bio
lead INDUSTRY
Principal Investigators
-
Maria Bermudez, MD, CPI · Quotient Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-07-12
- Primary Completion
- 2022-12-12
- Completion
- 2023-02-20
- FDA Drug
- Yes
Countries
- United States
Study Locations
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