NCT07094932

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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Trial in Healthy Adult Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBD09 With an 84-day Period of Fixed Daily Dosing

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Gates Medical Research Institute · Academic / Other
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	TBD09	TBD09 will be administered orally
DRUG	Placebo	Placebo will be administered orally

Timeline

• Start date: 2025-09-03
• Primary completion: 2026-01-11
• Completion: 2026-01-11
• First posted: 2025-07-31
• Last updated: 2026-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study