NCT03610334 - A Combined SAD and MAD Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of IFB-088 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 21, 2018

Primary Completion Date

June 21, 2019

Study Completion Date

December 16, 2019

Conditions

Healthy Volunteers

Interventions

DRUG

IFB-088 (2.5-60.0mg) oral capsule

SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours

DRUG

Placebo (2.5-60.mg) oral capsule

SAD phase: placebo (microcrystalline cellulosis) will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours

DRUG

IFB-088 (15.0-50.0mg) oral capsule

MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.

DRUG

Placebo oral (15.0-50.0mg) capsule

MAD phase: multiple doses of placebo (microcrystalline cellulosis, 15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.

Trial Locations (2)

13385

Centre d'Investigation Clinique - Centre de Pharmacologie Clinique et d'Evaluations Thérapeutiques (CIC-CPCET), Marseille

Unknown

"Eurofins, Optimed"