At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 467 enrolled
Drug / intervention
TPOXX +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating TPOXX and TPOXX Placebo for Smallpox. Completed, enrolled 467 participants across 9 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmallpox
CountriesUnited States
CollaboratorsUnited States Department of Defense
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedJul 2021
Enrollment StartMar 2022
Primary CompletionMay 2023
TodayJul 2026
First PostedJul 21, 2021
Enrollment StartMar 29, 2022
Primary CompletionMay 12, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.9 years ago
Interventions
TPOXXdrug
Study is based on Animal Regulatory Rule
TPOXX Placeboother
Does not apply