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

NCT03610334 | Completed Phase 1 Results

• 2 other identifiers: P1882018-000443-29
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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)

Conditions

Healthy Volunteers

Keywords

First-In-Human

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events Per Group

  This safety outcome lists the number of subjects experiencing adverse events (AEs), whether not related, possibly or unlikely related to the study treatment. As all the parameters are developped in the pharmacovigilance section, please do refer to that section for further details.

  SAD & MAD phases: Screening visit to End of study visit (7 to 14 days after last dosing) + 30 days

Secondary Outcomes (18)

• Number of Participants With Change in Concomitant Medications

  SAD & MAD phases: Continuous (Screening visit to End of study visit (7 to 14 days after last dosing) + 30 days)

• Pharmacokinetic: Maximum Observed Plasma Concentration (Cmax)

  Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)

• Pharmacokinetic: Time to Reach the Maximum Concentration in Plasma (Tmax)

  Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)

• Pharmacokinetic: Terminal Half-life (t1/2)

  Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)

• Pharmacokinetic: Area Under Plasma Concentration-time Curve From Hour 0 to Last Sample With Measurable Plasma Concentrations (AUClast)

  Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)

Other Outcomes (2)

• SAD Exploratory Biomarkers Analysis

  SAD phase: Day 1 at predose, 1.5 hours and 24 hours

• MAD Exploratory Biomarkers Analysis

  MAD phase: Day 1 and Day 14 at predose, 1.5 hours and 24 hours

Study Arms (18)

SAD IFB-088 2.5mg

EXPERIMENTAL

Cohort 1: A single daily dose of 2.5mg IFB-088 in oral capsule, is administered with 250 ml of water at room temperature, in the morning around 8:00am, in one intake

Drug: IFB-088 (2.5-60.0mg) oral capsule

SAD Placebo 2.5mg

PLACEBO COMPARATOR

Cohort 1: A single daily dose of 2.5mg placebo in oral capsule, is administered with 250 ml of water at room temperature, in the morning around 8:00am, in one intake

Drug: Placebo (2.5-60.mg) oral capsule

SAD IFB-088 5.0mg

EXPERIMENTAL

Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm

Drug: IFB-088 (2.5-60.0mg) oral capsule

SAD Placebo 5.0mg

PLACEBO COMPARATOR

Cohort 2: A single daily dose of 5.0mg placebo in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm

Drug: Placebo (2.5-60.mg) oral capsule

SAD IFB-088 10.0mg

EXPERIMENTAL

Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm

Drug: IFB-088 (2.5-60.0mg) oral capsule

SAD Placebo 10.0mg

PLACEBO COMPARATOR

Cohort 3: A single daily dose of 10.0mg Placebo in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm

Drug: Placebo (2.5-60.mg) oral capsule

SAD IFB-088 20.0mg

EXPERIMENTAL

Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm

Drug: IFB-088 (2.5-60.0mg) oral capsule

SAD Placebo 20.0mg

PLACEBO COMPARATOR

Cohort 4: A single daily dose of 20.0mg Placebo in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm

Drug: Placebo (2.5-60.mg) oral capsule

SAD IFB-088 40.0mg

EXPERIMENTAL

Cohort 5: A single daily dose of 40.0mg IFB-088 in oral capsule, divided in two doses of 20.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm

Drug: IFB-088 (2.5-60.0mg) oral capsule

SAD Placebo 40.0mg

PLACEBO COMPARATOR

Cohort 5: A single daily dose of 40.0mg Placebo in oral capsule, divided in two doses of 20.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm

Drug: Placebo (2.5-60.mg) oral capsule

SAD IFB-088 60.0mg

EXPERIMENTAL

Cohort 6: A single daily dose of 60.0mg IFB-088 in oral capsule, divided in two doses of 30.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm

Drug: IFB-088 (2.5-60.0mg) oral capsule

SAD Placebo 60.0mg

EXPERIMENTAL

Cohort 6: A single daily dose of 60.0mg Placebo in oral capsule, divided in two doses of 30.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm

Drug: Placebo (2.5-60.mg) oral capsule

MAD IFB-088 15 mg

EXPERIMENTAL

Cohort 7: subject taking 15.0mg of IFB-088 in oral capsule divided into 2 doses of 7.5mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days.

Drug: IFB-088 (15.0-50.0mg) oral capsule

MAD Placebo 15 mg

PLACEBO COMPARATOR

Cohort 7: subject taking 15.0mg of placebo in oral capsule divided into 2 doses of 7.5mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days.

Drug: Placebo oral (15.0-50.0mg) capsule

MAD IFB-088 30 mg

EXPERIMENTAL

Cohort 8: subject taking 30.0mg of IFB-088 in oral capsule divided into 2 doses of 15.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days.

Drug: IFB-088 (15.0-50.0mg) oral capsule

MAD Placebo 30 mg

PLACEBO COMPARATOR

Cohort 8: subject taking 30.0mg of Placebo in oral capsule divided into 2 doses of 15.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days.

Drug: Placebo oral (15.0-50.0mg) capsule

MAD IFB-088 50 mg

EXPERIMENTAL

Cohort 9: subject taking 50.0mg of IFB-088 in oral capsule divided into 2 doses of 25.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days.

Drug: IFB-088 (15.0-50.0mg) oral capsule

MAD Placebo 50 mg

PLACEBO COMPARATOR

Cohort 9: subject taking 50.0mg of Placebo in oral capsule divided into 2 doses of 25.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days.

Drug: Placebo oral (15.0-50.0mg) capsule

Interventions

IFB-088 (2.5-60.0mg) oral capsule DRUG

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

Also known as: verum

SAD IFB-088 10.0mg; SAD IFB-088 2.5mg; SAD IFB-088 20.0mg; SAD IFB-088 40.0mg; SAD IFB-088 5.0mg; SAD IFB-088 60.0mg

Placebo (2.5-60.mg) oral capsule DRUG

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

Also known as: placebo

SAD Placebo 10.0mg; SAD Placebo 2.5mg; SAD Placebo 20.0mg; SAD Placebo 40.0mg; SAD Placebo 5.0mg; SAD Placebo 60.0mg

IFB-088 (15.0-50.0mg) oral capsule DRUG

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.

Also known as: verum

MAD IFB-088 15 mg; MAD IFB-088 30 mg; MAD IFB-088 50 mg

Placebo oral (15.0-50.0mg) capsule DRUG

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.

Also known as: placebo

MAD Placebo 15 mg; MAD Placebo 30 mg; MAD Placebo 50 mg

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male 18 to 40 years of age inclusive, Caucasian.
• Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests, vital signs and ECG.
• AST, ALT, alkaline phosphatase and bilirubin \< or = 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
• ECG (12 leads) normal (120\<PR\<200ms; QRS\<120ms; QTcF\<450ms) and/or without clinically relevant impairments as judged by investigator.
• Non-smoker, or user of not more than tobacco- or nicotine-containing products ≤ 5 cigarettes a day.
• Negative screen for alcohol and drugs of abuse at screening and admission.
• No history of psychiatric disorders assessed by a clinical psychological evaluation and the Mini International Neuropsychiatric Interview (MINI).
• Body mass index (BMI) between 19 and 27 kg/m² inclusive.
• Subject with female partners of child bearing potential must agree to use one of the contraception methods listed in Section 6.6.1 (Contraception requirements). This criterion must be followed from the time of the first dose of study medication until the follow up visit (for female partners) and with an additional period of 90 days (for subjects themselves).
• Willing and able to understand and sign an approved Informed Consent Form.
• Able to understand the protocol and to come to the visits.
• Who is, in the judgement of the investigator likely to be compliant during the study.
• Subject registered in the VRB file (volontaires se prêtant à des recherches impliquant la personne humaine).
• Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.

You may not qualify if:

• \. History of asthma, anaphylaxis or anaphylactoid reactions, severe allergic responses.
• History of relevant atopy or drug hypersensitivity.
• Known allergy to any component of IFB-088 oral capsule or its placebo (HPMC or cellulose microcrystalline).
• History of major medical, psychiatric illness or surgery which, in the judgment of the investigator, puts them 'at risk' or is likely to modify their handling of the study drug.
• Acute or chronic systemic disease or disorder (respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine).
• Impaired renal function defined by a creatinine clearance \< 90 mL/min calculated using the Cockcroft-Gault equation (according the FDA Guidance for Industry: Pharmacokinetics in patients with Impaired Renal Function, March 2010).
• History of nephritic colic and/or renal calculi.
• History of drug abuse and/or regular use of tobacco- or nicotine-containing products \> 5/day within three months of the study.
• History of alcohol consumption exceeding, (on average 21 drinks/week for men) within 6 months of the first dose of study medication.
• Drinking excessive amounts of tea, coffee, chocolate and/or beverage containing caffeine (\> 4 cups / day).
• Vital signs with a clinically significant abnormality at screening.
• ECG with a clinically significant abnormality at screening.
• Laboratory test values outside the clinically acceptable 'normal range' for healthy volunteers at screening.
• Positive HIV, Hepatitis B or Hepatitis C at screening.
• Positive urine drug test or positive breath alcohol test at screening or at admission to the clinical unit.

Sponsors & Collaborators

• InFlectis BioScience: lead
• Qualissima: collaborator
• Assistance Publique Hopitaux De Marseille: collaborator
• Stragen France: collaborator
• Eurofins Optimed: collaborator

Study Sites (2)

Eurofins|Optimed

Gières, 38610, France

Location

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

Marseille, 13385, France

Location

Related Links

• Website of InFlectis BioScience

MeSH Terms

Interventions

calcium D-pantothenate, L-cysteine drug combination

Results Point of Contact

• Title: Dr Anne Visbecq (Chief Medical Officer)
• Organization: Inflectis Bioscience

annevisbecq@inflectisbioscience.com

0630632020

Study Officials

• Christine Audebert, MD

  APHM - Centre de Pharmacolgie Clinique et d'Evaluations Thérapeutiques

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Capsules used for verum or placebo (Size 5 white opaque HPMC capsule) are identical and equally-weighted
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: double-blind, randomized, placebo-controlled, combined single and multiple ascending dose of IFB-088 by successive cohorts study

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: August 1, 2018
• Study Start: June 21, 2018
• Primary Completion: June 21, 2019
• Study Completion: December 16, 2019
• Last Updated: January 26, 2022
• Results First Posted: January 26, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)