Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CB-0406 · 1 trial · 1 indication
Concentration of CB-0406 in plasma.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Cohort 1: 100 mg CB-0406 (n=6) |
| Cohort 2 | EXPERIMENTAL | Cohort 2: 200 mg CB-0406 (n=6). Dose initiated following review of all safety data from Cohort 1 by a Safety Review Committee |
| Cohort 3 | EXPERIMENTAL | Cohort 3: 400 mg CB-0406 (n=6). Dose initiated following review of all safety data and PK data from Cohort 2 by a Safety Review Committee. |
| 800 mg | EXPERIMENTAL | Cohort 4: 800 mg CB-0406 (n=6). Dose initiated following review of all safety data and PK data from Cohort 3 by a Safety Review Committee. |
| 1000 mg | EXPERIMENTAL | Cohort 5: 1000 mg CB-0406 (n=6). Dose initiated following review of all safety data and PK data from Cohort 4 by a Safety Review Committee |
| Matched placebo | PLACEBO_COMPARATOR | Two subjects in each Cohort (1, 2, 3, 4, 5) are randomized to matched placebo |
| Name | Type | Description |
|---|---|---|
| CB-0406 100 mg | DRUG | Single oral dose |
| CB-0406 200 mg | DRUG | Single oral dose |
| CB-0406 400 mg | DRUG | Single oral dose |
| CB-0406 800 mg | DRUG | Single oral dose |
| CB-0406 1,000 mg | DRUG | Single oral dose |
| Matched placebo | DRUG | Color and size matched placebo |
Inclusion Criteria: To be eligible for study entry participants must satisfy all of the following criteria: 1. Provide written informed consent before any study specific evaluation is performed; 2. Healthy adult male and female volunteers between the ages of 18 and 65 years, inclusive, at screenin...
CB-0406 is an investigational small molecule developed by Gilead Sciences, Inc. It has been studied in a Phase 1 clinical trial in healthy volunteers. The specific therapeutic indication for CB-0406 has not been disclosed.
CB-0406 is being developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. Gilead is the sponsor of the clinical program for this investigational small molecule.
CB-0406 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The program remains investigational and has not been approved by the FDA.
CB-0406 has been evaluated in a single Phase 1 trial, NCT04467684, titled "Study Investigating the Safety, Tolerability, and PK, PD, of CB-0406." The trial enrolled 90 healthy volunteers in Australia and is completed.