Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Days
NCT04971109Phase 3Completed
- Lead sponsor
- SIGA Technologies (Industry)
- Enrollment
- 467 (actual)
- Start date
- 29 Mar 2022
- Primary completion
- 12 May 2023 (actual)
- Study completion
- 12 May 2023
- Last update posted
- 11 Sep 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Double
- Arms
- 2
Interventions
- TPOXX Drug
- TPOXX Placebo Other
Conditions and primary outcome
- Smallpox
Primary outcome
Cmin (28 days); Cmax (28 days); AUC(0-last) - Total Systemic TPOXX Exposure (28 days); Time To Maximum TPOXX Exposure (28 days)
Posted results on ClinicalTrials.gov
Source: ClinicalTrials.gov results for NCT04971109 (opens in a new tab)· Licence: public-domain
First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25
Primary outcomes with a statistical analysis
No primary outcome with a statistical analysis is posted for this study.
Serious adverse events
Time frame: Adverse event data was collected from Day 1 though the Day 58 follow-up telephone call. All AEs were followed until stable or until resolution as determined by the investigator and/or medical monitor.
| Group | Affected | At risk |
|---|---|---|
| TPOXX | 1 | 369 |
| TPOXX Placebo | 1 | 95 |
Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT04971109.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT04971109 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Nothing on this page is medical or investment advice.