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 being developed for obese but otherwise healthy participants. It is currently in Phase 1 clinical development, with an active Phase 1b study evaluating its safety, pharmacokinetics, and efficacy in this population.
CRB-913 targets the CB1 receptor, a G protein-coupled receptor involved in metabolic regulation. By modulating this receptor, the drug is being studied for its potential effects in obesity, though its exact mechanism of action is still under clinical investigation.
CRB-913 is being developed by Corbus Pharmaceuticals Holdings, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CRBP. The company is conducting clinical trials for this asset in the metabolic therapeutic area.
CRB-913 is in Phase 1 clinical development. It is not yet approved by the FDA and remains investigational. The ongoing Phase 1b study is active but not recruiting participants, with a planned enrollment of 252 participants.
CRB-913 is being studied in a single active Phase 1b trial, NCT07310901, titled 'A 2-part, Phase 1b Clinical Study Designed to Evaluate the Safety, PK, and Efficacy of CRB-913 in Participants With Obesity.' This randomized, double-blind, placebo-controlled trial is being conducted in the United States.