Study of TRX-100 Evaluating the Safety, Pharmacokinetics, and Food Effect in Healthy Volunteers
A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of TRX-100 Evaluating the Safety, Pharmacokinetics, and Food Effect of Single Ascending Doses of TRX-100 in Healthy Volunteers
Traws Pharma, Inc.
32 participants
Mar 25, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
TRX-100 will be administered as a single oral dose on Day 1 with approximately 240 mL of noncarbonated room-temperature water. Active treatment is administered as 240 mg tablets in Cohort A, 480 mg tablets in Cohorts B and C, and 480 mg capsules in Cohort D. Study drug must be swallowed whole and must not be chewed, divided, dissolved, or crushed.
Matching tablet or capsule placebo will be administered as a single oral dose on Day 1 under the same meal and administration conditions as the corresponding active-treatment cohort.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07526506