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drugset / Trial / NCT03879928

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

NCT03879928 ↗

Phase 1 Completed 50 enrolled Future Medicine
RandomizedCrossoverDouble-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject FM101 Unknown 75 mg Oral
Subject FM101 Unknown 150 mg Oral
Subject FM101 Unknown 300 mg Oral
Subject FM101 Unknown 450 mg Oral
Subject FM101 Unknown 600 mg Oral
Subject FM101 Unknown 1200 mg Oral
Subject FM101 Unknown 2400 mg Oral

Indications

No indication recorded.