NCT07526506

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

A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of TRX-100 Tablets Evaluating the Safety, Pharmacokinetics, and Food Effect of Single Ascending Doses of TRX-100 in Healthy Volunteers

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Traws Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1b, randomized, double-blind, placebo-controlled, dose escalation study of TRX-100 tablets evaluating the safety, pharmacokinetics, and food effect of single ascending doses of TRX-100 in healthy volunteers.

Detailed description

This is a Phase 1b, randomized, double-blind, placebo-controlled, dose escalation study of TRX-100 tablets evaluating the safety, pharmacokinetics, and food effect of single ascending doses of TRX-100 in healthy volunteers. Participants will be enrolled in three cohorts evaluating two dose levels, 240 mg and 480 mg, under fed and fasted conditions.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	TRX-100 or placebo	The patient will receive TRX-100 or placebo

Timeline

• Start date: 2026-03-25
• Primary completion: 2026-09-01
• Completion: 2027-02-01
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: Australia