Clinical Trial

Study of TRX-100 Evaluating the Safety, Pharmacokinetics, and Food Effect in Healthy Volunteers

Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
This is a Phase 1b, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and food effect of single oral doses of TRX-100 tablets and capsules in healthy adult volunteers. Up to 32 participants will be enrolled in four cohorts and randomized within each cohort to receive TRX-100 or matching placebo.
Protocol Amendment History 3 changes
critical Primary endpoint(s) modified 2026-08-04
notable Enrollment increased: 24 -> 32 participants 2026-08-04
minor Trial arms changed: 3 -> 4 2026-08-04
Trial Details
NCT Number NCT07526506
Lead Sponsor Traws Pharma, Inc.
Conditions Healthy Volunteer
Enrollment 32 participants
Start Date 2026-03-25
Primary Completion 2026-09 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2026-08-03