https://clinicaltrials.gov/ct2/show/NCT03610334
A Combined SAD and MAD Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of IFB-088
A Combined SAD and MAD Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of IFB-088
ClinicalTrials.gov Identifier: NCT03610334
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : August 28, 2018
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Sponsor:
InFlectis BioScience
Collaborators:
Qualissima
Assistance Publique des Hôpitaux de Marseille – Pharmacometry department
Stragen France
Information provided by (Responsible Party):
InFlectis BioScience
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Study Description
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Brief 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)
Condition or disease Intervention/treatment Phase
Healthy Volunteers
Drug: IFB-088 oral capsule
Drug: Placebo oral capsule
Phase 1
