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

NCT07526506 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-08-03

No results posted yet for this study

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.

Conditions

  • Healthy Volunteer

Interventions

DRUG

TRX-100

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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • Traws Pharma, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2026-03-25
Primary Completion
2026-09-30
Completion
2027-02-28

Countries

  • Australia

Study Locations

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Entities

Drugs

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 NCT07526506 on ClinicalTrials.gov