NCT04165837

Safety, Tolerability, and Pharmacokinetics of Oral FB-101 in Healthy Subjects

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral FB-101 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: 1ST Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of oral doses of FB-101 in healthy subjects.

Detailed description

Part A * To assess the safety and tolerability of single ascending oral doses of FB-101 in healthy subjects. * To assess the pharmacokinetics (PK) of single ascending oral doses of FB-101 in healthy subjects. * To assess the effect of a high-fat meal on the PK of a single oral dose of FB-101 when administered to healthy subjects. Part B * To assess the safety and tolerability of multiple ascending oral doses FB-101 in healthy subjects. * To assess the PK of multiple ascending oral doses of FB-101 in healthy subjects.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	FB-101	Part A - Single Ascending Dose study Part B - Multiple Ascending Dose study
DRUG	Placebo	Part A - Single Ascending Dose matching placebo study Part B - Multiple Ascending Dose matching placebo study

Timeline

• Start date: 2019-10-14
• Primary completion: 2021-11-12
• Completion: 2022-07-14
• First posted: 2019-11-18
• Last updated: 2023-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study