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NCT04971109 · ClinicalTrials.gov registry record · Phase 3
Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Days
A Phase 3 study, sponsored by SIGA Technologies.
- Completed
- Registry status
- Phase 3
- Development phase
- 467
- Enrollment target
NCT04971109 is a Phase 3 study that has completed, run by SIGA Technologies. The registered enrollment target is 467 participants.
The verdict
NCT04971109, a Phase 3 study, has completed, sponsored by SIGA Technologies.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 467 participants
- Enrollment target
Study 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.
Interventions
- DRUG TPOXX
- OTHER TPOXX Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 467 participants |
| Start Date | 2022-03-29 |
| Est. Completion | 2023-05-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04971109
The ClinicalTrials.gov registry entry for NCT04971109 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 467 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SIGA Technologies, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which TPOXX is the first listed.
NCT04971109 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04971109 about?
NCT04971109 is a clinical study titled "Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Days". 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.
What is the current status of trial NCT04971109?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 467 participants. The study started on 2022-03-29. Estimated completion is 2023-05-12.
What interventions are being tested in trial NCT04971109?
The interventions under investigation include: TPOXX (DRUG), TPOXX Placebo (OTHER).
Who is sponsoring clinical trial NCT04971109?
This trial is sponsored by SIGA Technologies, which has 8 total clinical trials registered on ClinicalTrials.gov.
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