NCT06088784

A Study Assessing the Safety of Oral ATH-399A in Healthy Adult Participants

A Randomized, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses as Well as the Food Effect of Orally Administered ATH-399A in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: HanAll BioPharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety, tolerability and pharmacokinetics of single and multiple doses of ATH-399A in healthy adults and also evaluate the effect of food on ATH-399A in order to develop mechanism-based and/or disease-modifying treatments for Parkinson Disease.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ATH-399A	Orally administered drug in capsule form.
DRUG	Placebo	Orally administered drug in capsule form.
DRUG	ATH-399A 10 mg	Participants will receive single oral dose of 10 mg of ATH-399A capsule
DRUG	5 mg ATH-399A capsule	Participants will receive single oral dose of 5mg of ATH-399A capsule
DRUG	20mg ATH-399A capsule	Participants will receive single oral dose of 20mg of ATH-399A capsule
DRUG	40mg ATH-399A capsule	Participants will receive single oral dose of 40mg of ATH-399A capsule
DRUG	80mg ATH-399A capsule	Participants will receive single oral dose of 80mg of ATH-399A capsule

Timeline

• Start date: 2023-09-19
• Primary completion: 2024-04-24
• Completion: 2024-04-24
• First posted: 2023-10-18
• Last updated: 2025-12-19
• Results posted: 2025-12-19

Locations

1 site across 1 country: Canada