NCT03879928 - A SAD, MAD, and FE Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of FM101 in Healthy Volunteers | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 8, 2019

Primary Completion Date

August 18, 2019

Study Completion Date

May 1, 2020

Conditions

Healthy Subjects

Interventions

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.

Trial Locations (1)

PRA health Sciences, Groningen