Phase 1Completed
A 2-part, Phase 1b Clinical Study Designed to Evaluate the Safety, PK, and Efficacy of CRB-913 in Participants With Obesity (CANYON-1)
A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Dose-Range Finding Study of the Efficacy, Safety, and Pharmacokinetics of CRB-913 in Participants With Obesity With a Single Cohort Open-label Exploratory Pharmacokinetic Lead-In
- Sponsor
- Corbus Pharmaceuticals Inc. (Industry)
- Enrolment
- 254 enrolled
- Conditions
- Obese But Otherwise Healthy Participants
- Interventions
- CRB-913; Placebo
- Ages
- adults, older adults
- Registry
- NCT07310901
Full record on ClinicalTrials.gov
From the registry
This study will assess the safety of the investigational drug CRB-913 and how it is processed in the body. The study has two parts: Part 1 will measure drug levels in healthy adults after taking CRB-913 tablets, and Part 2 will compare three doses of CRB-913 with placebo to evaluate safety, effects on body weight, and drug levels in the blood. Part 2 is blinded, meaning participants, study doctors, and the sponsor will not know which treatment is given. Participants in Part 2 will take study treatment for 12 weeks and will be followed for 28 days after treatment ends.
Primary outcomes
- Part 1: To evaluate the PK of a single dose of CRB-913 - Cmax
- Part 1: To evaluate the PK of a single dose of CRB-913 - Tmax
- Part 1: To evaluate the PK of a single dose of CRB-913 - T1/2
- Part 2: To evaluate the safety of CRB-913 - TEAE
History
Last registry update
Primary completion
Registered
Started