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

NCT03610334 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2022-01-26

Study results available
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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)

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.

Sponsors & Collaborators

  • Qualissima

    collaborator OTHER

  • Assistance Publique Hopitaux De Marseille

    collaborator OTHER

  • Stragen France

    collaborator INDUSTRY

  • Eurofins Optimed

    collaborator INDUSTRY

  • InFlectis BioScience

    lead INDUSTRY

Principal Investigators

  • Christine Audebert, MD · APHM - Centre de Pharmacolgie Clinique et d'Evaluations Thérapeutiques

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • France

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 NCT03610334 on ClinicalTrials.gov