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A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBD09

NCT07094932 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-01-22

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, multiple dose trial of TBD09, administered to healthy adult participants to assess safety, tolerability, and pharmacokinetics up to 84 days of fixed daily dosing of TBD09. The trial will be conducted with two cohorts, with participants enrolled in parallel and randomized to receive either TBD09 or placebo.

Conditions

  • Healthy Adult Participants

Interventions

DRUG

TBD09

TBD09 will be administered orally

DRUG

Placebo

Placebo will be administered orally

Sponsors & Collaborators

  • Gates Medical Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-03
Primary Completion
2026-01-11
Completion
2026-01-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT07094932 on ClinicalTrials.gov