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Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Day

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Contents

clinicaltrials.gov/study/NCT04971109
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT049711090
Health Conditions in Trial
Smallpox
Smallpox
0
Trial Recruitment Size
4670
Trial Sponsor
SIGA Technologies
SIGA Technologies
0
Clinical Trial Start Date
March 29, 2022
0
Primary Completion Date
May 12, 2023
0
Study Completion Date
May 12, 2023
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Drug0
Other0
Intervention Name
TPOXX Placebo0
TPOXX0
Interventional Trial Phase
Phase 30
Participating Facility
‌
Midwest Clinical Research Center
0
‌
Coastal Carolina Research Center
0
Advanced Pharma
Advanced Pharma
0
High Point Clinical Trials Center
High Point Clinical Trials Center
0
‌
Hassman Research Institute
0
Official Name
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 Subjects0
Last Updated
July 19, 2023
0
Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Double0
Masked Party
Investigator0
Participant0
Study summary

This is a study to assess the safety, tolerability, and PK of oral TPOXX 600 mg when administered BID for 28 days in adult subjects.

Timeline

No Timeline data yet.

Further Resources

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