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drugset / Trial / NCT03610334

A Combined SAD and MAD Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of IFB-088

NCT03610334 ↗

Phase 1 Completed 72 enrolled InFlectis BioScience Assistance Publique Hopitaux De Marseille · collabEurofins Optimed · collabQualissima · collabStragen France · collab
RandomizedParallel-groupQuadruple-blindOther

Summary

This is the first study of single and multiple doses of IFB-088 in human subjects. The current study is designed to assess in the first part, the safety, tolerability, plasma and urine pharmacokinetics (PK) of single oral doses of IFB-088 in healthy subjects (Single Ascending Doses - SAD) and in a second part safety, tolerability, plasma and urine pharmacokinetics (PK) of multiple oral doses of IFB-088 in healthy subjects (Multiple Ascending Doses - MAD)

Timeline

Start
2018-06-21
Primary completion
2019-06-21
Completion
2019-12-16

Drugs

EvaluationDrugModalityDoseRoute
Subject IFB-088 Unknown 2.5 mg Oral
Subject IFB-088 Unknown 5 mg Oral
Subject IFB-088 Unknown 10 mg Oral
Subject IFB-088 Unknown 15 mg Oral
Subject IFB-088 Unknown 20 mg Oral
Subject IFB-088 Unknown 30 mg Oral
Subject IFB-088 Unknown 40 mg Oral
Subject IFB-088 Unknown 50 mg Oral
Subject IFB-088 Unknown 60 mg Oral

Indications

No indication recorded.