NCT06757738

A Clinical Study Aiming to Assess Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TRX-100 in Healthy Volunteers

A Randomized, Double-Blind, Placebo-Controlled, Phase 1, Dose Escalation (With Optional Food Effect) Study of Orally Administered TRX-100 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of TRX-100 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Traws Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This is a clinical study aiming to assess pharmacokinetics, pharmacodynamics and preliminary efficacy of TRX-100 (and its major active metabolite TRX-101) in Healthy Volunteers

Detailed description

This is a Phase 1, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, PK, PD of orally administered TRX-100 (and its major active metabolite TRX-101) in Healthy Volunteers. The study will be conducted in 1 part only, as a single ascending dose (SAD) study at up to 4 dose levels. Evaluation of dose levels will be conducted in a sequential fashion with lower dose levels evaluated first in the sequence.

Conditions

• Healthy Volunteer Study

Interventions

Type	Name	Description
DRUG	TRX-100	CEN inhibitor, dosage form - capsules, dosing regimen - QD
DRUG	Placebo	Placebo, dosage form - capsules, dosing regimen - QD

Timeline

• Start date: 2024-08-13
• Primary completion: 2025-01-16
• Completion: 2025-01-24
• First posted: 2025-01-03
• Last updated: 2026-01-21

Locations

1 site across 1 country: Australia