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 being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial that assessed its safety, tolerability, pharmacokinetics, and pharmacodynamics. The drug is not approved for any condition and remains in early-stage clinical research.
CB-0406 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting clinical research on this investigational small molecule, which is currently in Phase 1 development.
CB-0406 is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. A single Phase 1 trial has been completed, and the drug remains in early-stage clinical research, with no active trials currently listed.
CB-0406 has one completed clinical trial, identified as NCT04467684. This Phase 1 study, titled "Study Investigating the Safety, Tolerability, and PK, PD, of CB-0406," enrolled 90 healthy volunteers in Australia. The trial was randomized, double-blind, and placebo-controlled, and it has been completed.
CB-0406 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug has completed a Phase 1 trial in healthy volunteers, but it has not received regulatory approval for any medical use.