drugset / Trial / NCT06707142

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

NCT06707142 ↗

Phase 1 Completed 124 enrolled Gates Medical Research Institute
RandomizedSequentialQuadruple-blindTreatment

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).

Timeline

Start
2024-12-05
Primary completion
2026-02-27
Completion
2026-02-27

Drugs

EvaluationDrugModalityDoseRoute
Subject TBD11 Unknown — Oral

Indications

No indication recorded.