clinical trial · NCT04971109
Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Days
SIGA Technologies·phase3·completed·n = 467
SmallpoxTPOXXTPOXX Placebo
brief 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.
started
Mar 29, 2022
primary completion
May 12, 2023
completion
May 12, 2023
last updated
Dec 27, 2024
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.
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol