NCT03879928

A SAD, MAD, and FE Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of FM101 in Healthy Volunteers

A Randomized, Double-blind, Placebo-controlled, Alternating Panel Single Ascending Dose, Sequential Multiple Ascending Dose, and Food Effect Study of FM101 in Healthy Male and Female Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Future Medicine · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This a double blind, randomized, placebo controlled, single and multiple ascending dose (SAD/MAD) study in healthy subjects. Safety evaluation will include adverse events (TEAEs), clinical laboratory values, vital signs, ECGs, and physical examinations.

Detailed description

This is a randomized, double-blind, placebo-controlled study in healthy volunteers designed to assess the safety, tolerability and PK of FM101. This study will consist of 3 parts: a SAD part, a single dose FE part and a MAD part. Each subject is to participate in only 1 part of the study.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Single ascending doses of FM101	The study drug (FM101 and placebo comparator) will be administered orally as SAD doses
DRUG	Multiple ascending doses of FM101	The study drug (FM101 and placebo comparator) will be administered orally as MAD doses
DRUG	Food effects of FM101	The study drug (FM101) will be administered orally under fasted condition and fed condition.

Timeline

• Start date: 2019-01-08
• Primary completion: 2019-08-18
• Completion: 2020-05-01
• First posted: 2019-03-19
• Last updated: 2020-09-09

Locations

1 site across 1 country: Netherlands