Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CRB-913 · 1 trial · 1 indication
Maximum plasma concentration (Cmax)
Time to maximum plasma concentration (Tmax)
Terminal elimination half-life (T1/2)
Incidence and severity of treatment emergent adverse events
Incidence of adverse events of special interest
| Arm | Type | Description |
|---|---|---|
| Part 1: PK Lead-in | EXPERIMENTAL | Primary Treatment Period (Day 1): Participants will receive a single dose of CRB-913. Following Part 1 of the study Part 2 will open for recruitment. Safety Follow-up Period: Participants who complete or discontinue the primary treatment period are followed for safety for 28 days. No treatment is administered during this period. |
| Part 2: CRB-913 low dose | EXPERIMENTAL | Primary Treatment Period (Day 0-Day 85): Participants will receive CRB-913 low dose which is maintained up to day 85. Safety Follow-up Period: Participants who complete or discontinue the primary treatment period are followed for safety for 28 days. No treatment is administered during this period. |
| Part 2: CRB-913 Medium Dose | EXPERIMENTAL | Primary Treatment Period (Day 0-Day 85): Participants will receive CRB-913 starting at low dose for 14 days and increasing to medium dose at day 15 which is maintained up to day 85. Safety Follow-up Period: Participants who complete or discontinue the primary treatment period are followed for safety for 28 days. No treatment is administered during this period. |
| Part 2: CRB-913 High Dose | EXPERIMENTAL | Primary Treatment Period (Day 0 - Day 85): Participants will receive CRB-913 starting at low dose for 14 days, increasing to medium dose at day 15 for 14 days and then increased to high dose at day 29 which is maintained up to day 85. Safety Follow-up Period: Participants who complete or discontinue the primary treatment period are followed for safety for 28 days. No treatment is administered during this period. |
| Part 2: Placebo | PLACEBO_COMPARATOR | Primary Treatment Period (Day 0-Day 85): Participants will receive CRB-913 matching placebo which is maintained up to day 85. Safety Follow-up Period: Participants who complete or discontinue the primary treatment period are followed for safety for 28 days. No treatment is administered during this period. |
| Name | Type | Description |
|---|---|---|
| CRB-913 | DRUG | Administered QD |
| Placebo | DRUG | Administered QD |
Inclusion Criteria: * Part 1: Participants with BMI 18.0-25.0 kg/m² * Part 2: Obese participants with BMI ≥30 kg/m² Exclusion Criteria: * Significant liver disease or moderate-severe hepatic impairment * History of seizures, epilepsy, or intracranial surgery * Diabetes mellitus (Type 1 or Type 2)...
CRB-913 is an investigational small molecule developed by Corbus Pharmaceuticals Holdings, Inc. for obesity in otherwise healthy participants. It is a CB1 receptor-targeted therapy in the metabolic therapeutic area and has completed a Phase 1b clinical study. It is not yet approved for any indication.
CRB-913 is being developed for the treatment of obesity in otherwise healthy participants. It is an investigational therapy in the metabolic therapeutic area and has been studied in a Phase 1b clinical trial. It is not approved for any use.
CRB-913 targets the CB1 receptor, a receptor in the endocannabinoid system. By interacting with CB1, the drug is designed to modulate metabolic pathways relevant to obesity. It is a small molecule therapeutic being developed by Corbus Pharmaceuticals.
CRB-913 is being developed by Corbus Pharmaceuticals Holdings, Inc., which trades under the ticker CRBP. The company is advancing the drug as an investigational treatment for obesity in otherwise healthy participants.
CRB-913 is in Phase 1 development. A Phase 1b clinical study in participants with obesity has been completed. The drug remains investigational and has not been approved by the FDA for any indication.
CRB-913 has been evaluated in a single Phase 1b clinical trial, NCT07310901, titled a 2-part study to evaluate the safety, PK, and efficacy of CRB-913 in participants with obesity. The trial enrolled 254 participants in the United States and is completed.