A Phase 1, SAD and MAD to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral FB-101 in Healthy Adult Male Subjects

Summary

This is a Phase 1, randomized, double-blind, placebo-controlled study consisting of SAD and MAD investigation at a single clinical trial center conducted in healthy adult male subjects assessing the safety, tolerability, PK, and PD of oral FB-101 administration. Up to 72 healthy adult male subjects will be enrolled. Additional subjects may be enrolled (8 subjects per cohort) if it is deemed appropriate following review (e.g., in the circumstances where a dose level is repeated, or an intermediate dose is conducted or to add another dose level(s) (higher than those planned)).

Timeline

Start

2025-11

Primary completion

2026-06

Completion

2027-06

Drugs

Indications

No indication recorded.