NCT07024589

First-in-Human Trial of Oral AN2-502998

A Phase 1, Single-Center, Randomized, Blinded, Placebo-Controlled Trial in Healthy Adults to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Oral AN2-502998

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: AN2 Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

First-in-Human Phase 1, Single-Center, Randomized, Blinded, Placebo-Controlled Trial in Healthy Adults to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Oral AN2-502998

Detailed description

First-in-human Phase 1, Single-Center, Randomized, Blinded, Placebo-Controlled Trial in Healthy Adults to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Oral AN2-502998 Part A (SAD; Groups SAD1-SAD6): Part A is the Single Ascending Dose (SAD) portion of the trial that will be conducted in approximately 48 healthy adults in approximately 6 groups. Eight participants in each group will be randomized in a 6:2 ratio to receive a single dose of AN2-502998 or matching PBO, respectively (6 AN2-502998:2 PBO). Part B (MAD; Groups MAD1-MAD3): Part B is the Multiple Ascending Dose (MAD) portion of the trial that will be conducted in approximately 24 healthy adults in approximately 3 groups. Eight participants in each group will be randomized in a 6:2 ratio to receive multiple doses of AN2-502998 or matching PBO (6 AN2 502998:2 PBO) QD for 10 days.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	AN2-502998	Oral Capsule
DRUG	Placebo	Oral Capsule

Timeline

• Start date: 2025-08-04
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2025-06-17
• Last updated: 2026-01-08

Locations

1 site across 1 country: Australia