A Combined SAD and MAD Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of IFB-088
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

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)
    

Detailed description: 
      Randomized, double blind, placebo controlled study of single ascending doses (SAD) and
      multiple ascending doses (MAD).

      The SAD part consists of 6 cohorts of 8 healthy young male subjects, each receiving a single
      oral dose of IFB-088 or placebo (6 verum and 2 placebo). In each cohort, 2 subjects (1 verum
      and 1 placebo) will be dosed first. If the safety and tolerability results are acceptable,
      the 6 remaining subjects will be dosed by 2 successive groups of 3 subjects, with an adequate
      period between the 2 groups to detect the occurrence of any reaction or adverse events,
      namely at least 48H for the first cohort and at least 36H for the following cohorts. Indeed,
      in the first cohort (2.5 mg IFB-088 base), dosing will be in the morning only. From the
      second cohort, the planned daily dose will be divided into 2 doses separated by an interval
      of 12 hours (1 dose in the morning fasting and 1 dose in the evening 2 hours before dinner).

      The MAD part consists of 3 cohorts of 8 healthy young male subjects, each receiving an oral
      dose divided into two doses of IFB-088 or placebo (6 verum and 2 placebo) for 14 days. In
      each cohort, the 2 first subjects will be dosed on Day 1 (one on active treatment and one on
      placebo). The 6 remaining subjects will be dosed by 2 successive groups of maximum 3 subjects
      with an adequate period between the groups to observe for any reaction and adverse events.
      This period will be of at least 36H, corresponding to at least 5-fold the half-life of the
      drug (based on results obtained during the SAD part) when steady state will be achieved. In
      each MAD cohort, the total daily dose will be divided into 2 doses separated by an interval
      of 12 hours.
    

Intervention name(s): IFB-088 (2.5-60.0mg) oral capsule; Placebo (2.5-60.mg) oral capsule; IFB-088 (15.0-50.0mg) oral capsule; Placebo oral (15.0-50.0mg) capsule
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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; 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; 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.; 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.
Other intervention name(s): verum; placebo; verum; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double-blind, randomized, placebo-controlled, combined single and multiple ascending dose of IFB-088 by successive cohorts study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: First-In-Human