Trials / Completed
CompletedNCT04971109
Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Days
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of TPOXX When Administered Orally for 28 Days in Adult Subjects
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 467 (actual)
- Sponsor
- SIGA Technologies · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
This is a study to assess the safety, tolerability, and PK of oral TPOXX 600 mg when administered twice daily (BID) for 28 days in adult subjects.
Detailed description
This is a Phase 3, multicenter, double-blind, randomized, placebo-controlled study to assess the safety, tolerability, and PK of oral TPOXX 600 mg when administered BID for 28 days in adult subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TPOXX | Study is based on Animal Regulatory Rule |
| OTHER | TPOXX Placebo | Does not apply |
Timeline
- Start date
- 2022-03-29
- Primary completion
- 2023-05-12
- Completion
- 2023-05-12
- First posted
- 2021-07-21
- Last updated
- 2024-12-27
- Results posted
- 2024-10-23
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04971109. Inclusion in this directory is not an endorsement.