Clinical Trial

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

Completed Phase 1
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-07-29; most recent amendment 2026-01-21.
Status change: Active, Not Recruiting → Completed 2026-01-21
Status change: Recruiting → Active, Not Recruiting 2025-10-29
Status change: Not Yet Recruiting → Recruiting 2025-10-01
Trial Details
NCT Number NCT07094932
Lead Sponsor Gates Medical Research Institute
Conditions Healthy Adult Participants
Enrollment 36 participants
Start Date 2025-09-03
Primary Completion 2026-01-11 (estimated)
Study Completion 2026-01-11 (estimated)
Updated on ClinicalTrials.gov 2026-01-22