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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07211607 | I.V. Selonabant in Healthy Adult Subjects | PHASE1 | COMPLETED | 40 | — | — | Sep 22, 2025 | May 6, 2026 | May 8, 2026 | 1 | United States |
The minimum possible Beck Depression Inventory (BDI) score is 0, and the maximum score is 63. This score is determined by summing the ratings from the 21 questions, with each question scoring from 0 to 3, indicating the severity of depressive symptoms over the past two weeks. Lower score means less depression
The Columbia-Suicide Severity Rating Scale (C-SSRS) does not have a single minimum or maximum score, as it is not a traditional cumulative-score test. Instead, it uses a series of "yes" or "no" questions to place an individual into distinct categories of risk based on their specific responses. Lower score means less suicidal ideation.
Pharmacokinetic clearance (\\(CL\\)) is a quantitative measure of how efficiently the body removes a drug from the bloodstream. It is defined as the volume of plasma from which a drug is completely and irreversibly removed per unit of time and is typically expressed in units like milliliters per minute (mL/min) or liters per hour (L/h).
| Arm | Type | Description |
|---|---|---|
| Experimental Cohort 1 | EXPERIMENTAL | Single intravenous dose of 1 mg of selonabant or placebo |
| Experimental Cohort 2 | EXPERIMENTAL | Single intravenous dose of 2 mg of selonabant or placebo |
| Experimental Cohort 3 | EXPERIMENTAL | Single intravenous dose of 5 mg of selonabant or placebo |
| Experimental Cohort 4 | EXPERIMENTAL | Single intravenous dose of 10 mg of selonabant or placebo |
| Experimental Cohort 5 | EXPERIMENTAL | Single intravenous dose of 20 mg of selonabant or placebo |
| Name | Type | Description |
|---|---|---|
| selonabant | DRUG | Intravenous infusion of selonabant |
| placebo | DRUG | Placebo infusion which looks the same as the selonabant infusion |
Key Inclusion Criteria: 1. The subject is male or female 18 to 30 years of age, inclusive. 2. The subject has a body mass index of 18 to 30 kg/m2, inclusive, and with a minimum weight of 50 kg and maximum weight of 110 kg. 3. The subject has no clinically significant medical history and no clinical...