NCT06432647

A SAD and MAD Study of the Safety, Tolerability, and Pharmacokinetics of ATH-1105

ATH-1105 A Phase 1, Double-Blind, Placebo-Controlled, Single-and-Multiple-Oral-Dose, Safety, Tolerability, and Pharmacokinetic Study in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: LeonaBio · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this Phase 1 interventional study is to assess the safety, tolerability and pharmacokinetics of ATH-1105 in healthy male and female participants.

Detailed description

The study is a Phase 1, First-In-Human study consisting of two parts (A and B). Part A will comprise a single-dose, double-blind, placebo-controlled, sequential-group design. Part B will comprise a multiple-dose, placebo-controlled, sequential-group design.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ATH-1105	ATH-1105 in oral form. Participants will be administered ATH-1105 once in Part A and once daily for 10 days in Part B.
DRUG	Placebo	Placebo in oral form. Participants will be administered Placebo once in Part A and once daily for 10 days in Part B.

Timeline

• Start date: 2024-04-24
• Primary completion: 2024-11-25
• Completion: 2024-11-25
• First posted: 2024-05-29
• Last updated: 2025-01-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study