NCT06707142

A Trial in Healthy Adult Participants to Evaluate the Safety, Tolerability, and Behavior in the Body of TBD11

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose and Multiple Ascending Dose Trial in Healthy Adult Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of TBD11 With an Open Label (Single Dose) Food Effect Panel

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 124 (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 First in human (FIH) trial of TBD11, administered to healthy adults. The trial will be conducted in two parts. Part 1 will consist of single ascending dose (SAD) and Food effect (FE) cohorts, and Part 2 will consist of multiple ascending dose (MAD) cohorts and tablet formulation evaluation (Part 2, Cohort 4).

Conditions

• Healthy Adult Participants

Interventions

Type	Name	Description
DRUG	TBD11	TBD11 will be administered orally.
DRUG	Placebo	Placebo will be administered orally.

Timeline

• Start date: 2024-12-05
• Primary completion: 2026-02-27
• Completion: 2026-02-27
• First posted: 2024-11-27
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study