NCT05169671

Safety, Tolerability, and Pharmacokinetics Study of ATH-1020

A Randomized, Placebo-Controlled, Double-Blinded, First-in-Human, Adaptive Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (Part A) and Multiple Ascending Doses (Part B) of Orally Administered ATH-1020 in Healthy Young and Elderly Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: LeonaBio · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This Phase 1 randomized, placebo-controlled, double-blinded, first-in-human study will evaluate safety, tolerability, and pharmacokinetics of single and multiple ascending doses of ATH-1020 in healthy young and elderly subjects.

Detailed description

This is a Phase 1 first-in-human, 2-part adaptive study. Both Part A and Part B will be performed in a randomized, placebo-controlled, and double-blind manner. Part A - Single Ascending Dose (SAD) Part A will be a SAD study investigating multiple dose levels of ATH 1020. Part B - Multiple Ascending Dose (MAD) Part B will be a multiple ascending dose (MAD) study investigating multiple dose levels of ATH-1020. Subjects in Cohort B5 (4 subjects) will additionally undergo CSF sampling pre-dose on Day 4 and up to 3 post dose timepoints to evaluate ATH-1020 blood-brain-barrier penetration

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ATH-1020	ATH-1020 in oral capsule form
DRUG	Placebo	Placebo in oral capsule form

Timeline

• Start date: 2022-03-30
• Primary completion: 2022-09-09
• Completion: 2022-09-09
• First posted: 2021-12-27
• Last updated: 2024-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study