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

NCT03879928 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-09-09

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Future Medicine

    lead INDUSTRY

Principal Investigators

  • WanSeok Jeong, MBA · Future Medicine Ltd.

  • Renger Tiessen, PhD · PRA Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-08
Primary Completion
2019-08-18
Completion
2020-05-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03879928 on ClinicalTrials.gov