Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04467684 | Study Investigating the Safety, Tolerability, and PK, PD, of CB-0406 | PHASE1 | COMPLETED | 90 | — | — | Jul 7, 2020 | Jun 6, 2021 | Jun 11, 2021 | 1 | Australia |
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...