NCT05995782

A Phase 1, SAD and MAD Study to Evaluate the Safety and Tolerability of FB418

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, SAD and MAD Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral FB418 in Healthy Adult Subjects and Healthy Elderly Subjects

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: 1ST Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics and pharmacodynamics of oral doses of FB418 in healthy adult subjects and healthy elderly subjects.

Detailed description

Part A: Primary: To assess the safety and tolerability of single ascending oral doses of FB418 in healthy adult subjects and healthy elderly subjects. Secondary: To assess the pharmacokinetics (PK) of FB418 and metabolite after single ascending oral doses of FB418 in healthy adult subjects and healthy elderly subjects. To assess the effect of a high-fat meal on the PK of FB418 and metabolite after a single oral dose of FB418 when administered to healthy adult subjects. Part B: Primary: To assess the safety and tolerability of multiple ascending oral doses FB418 in healthy adult subjects. Secondary: To assess the PK of FB418 and metabolite after multiple ascending oral doses of FB418 in healthy adult subjects.

Conditions

• Parkinson Disease Psychosis
• Amyotrophic Lateral Sclerosis (ALS)

Interventions

Type	Name	Description
DRUG	FB418	Oral dose

Timeline

• Start date: 2023-12-20
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2023-08-16
• Last updated: 2024-12-02

Locations

1 site across 1 country: South Korea