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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04971109 | Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Days | PHASE3 | COMPLETED | 467 | — | — | Mar 29, 2022 | May 12, 2023 | Dec 27, 2024 | 9 | United States |
Cmin - Minimum TPOXX concentration in plasma
Peak exposure when administered TPOXX
Total systematic exposure when administered TPOXX
Median hours post dose when administered TPOXX
| Arm | Type | Description |
|---|---|---|
| TPOXX | ACTIVE_COMPARATOR | Treatment Group 1: An oral dose of 600 mg (3 x 200 mg capsules)TPOXX |
| TPOXX Placebo | PLACEBO_COMPARATOR | Treatment Group 2: An oral dose of placebo (3 capsules identical to TPOXX) |
| Name | Type | Description |
|---|---|---|
| TPOXX | DRUG | Study is based on Animal Regulatory Rule |
| TPOXX Placebo | OTHER | Does not apply |
Inclusion Criteria: 1. Subject is male or female between 18 and 80 years of age, inclusive. 2. Subject is available for clinical follow-up for the duration of the study. 3. Women of childbearing potential have a negative beta human chorionic gonadotropin pregnancy test (serum) at the screening visi...