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

NCT04971109 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 467

Last updated 2024-12-27

Study results available
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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.

Conditions

Interventions

DRUG

TPOXX

Study is based on Animal Regulatory Rule

OTHER

TPOXX Placebo

Does not apply

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • SIGA Technologies

    lead INDUSTRY

Principal Investigators

  • Dennis Hruby · SIGA Technologies

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-29
Primary Completion
2023-05-12
Completion
2023-05-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04971109 on ClinicalTrials.gov