RecruitingPhase 1NCT05995782

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

Sponsor

1ST Biotherapeutics, Inc.

Enrollment

64 participants

Start Date

Dec 20, 2023

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease Psychosis

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.

Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This is an early-phase safety study of a new investigational drug called FB418, to see how the human body tolerates and processes it. The study tests different doses in healthy volunteers before testing in patients with medical conditions. **You may be eligible if...** - You are a healthy adult male between 19 and 55 years old (for most parts of the study) - For the elderly cohort only: you are a healthy male or female (not able to become pregnant) over 60 years old - You are a non-smoker and have not used nicotine products recently - You are not currently taking any regular medications (or can stop them safely before the study) **You may NOT be eligible if...** - You have significant active health conditions - You smoke or use nicotine products - You are a woman of childbearing potential (except elderly women in the specific elderly cohort) - You are outside the specified age ranges Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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