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

Amyotrophic Lateral Sclerosis (ALS) Clinical Trial

Official title: 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 Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Amyotrophic Lateral Sclerosis (ALS)
• Motor Neuron Disease
• Parkinson Disease
• Parkinson Disease Psychosis

• NCT number: NCT05995782
• Study type: Interventional
• Source: 1ST Biotherapeutics, Inc.
• Contact: 1STBIO information team
• Phone: +82-31-895-4677
• Email: info@1stbio.com
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: December 2023
• Completion date: December 2024