NCT04476303

A Study to Evaluate the Pharmacokinetics and Safety of BEY2153 in Healthy Participants

A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of BEY2153 After Oral Administration in Healthy Young and Elderly Male Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: BeyondBio Inc. · Industry
• Sex: Male
• Age: 19 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This is a first in human Phase 1 study to evaluate the safety, tolerability and pharmacokinetics with healthy young and elderly adult male volunteers after receiving single and multiple ascending dose of BEY2153.

Detailed description

Healthy young and elderly adult volunteers who meet the criteria, will be treated single and multiple ascending dose of BEY2153 or placebo orally. Food effect evaluation study will be conducted with single ascending dose. After the single ascending dose study, independent external experts will review blinded data and multiple ascending dose study will be conducted.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	BEY2153	Capsule

Timeline

• Start date: 2020-08-27
• Primary completion: 2021-11-23
• Completion: 2021-11-23
• First posted: 2020-07-20
• Last updated: 2025-03-10

Locations

1 site across 1 country: South Korea