Healthy VolunteersPhase 1NCT03610334
A Combined SAD and MAD Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of IFB-088
A Phase 1 study testing IFB-088 (2.5-60.0mg) oral capsule and IFB-088 (15.0-50.0mg) oral capsule in people with Healthy Volunteers, run by InFlectis BioScience at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- IFB-088 (2.5-60.0mg) oral capsule and IFB-088 (15.0-50.0mg) oral capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesFrance
- Study dates
- 21 Jun 2018to 16 Dec 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 1. 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).
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- 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.
- Any medication (including St John's Wort) within 14 days before administration, or within 5 times the elimination half-life of that drug, whichever is the longest (except paracetamol).
- Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening.
- Unable to refrain from consumption of grapefruit or grapefruit juice within 7 days prior to the first dose of study medication.
- Unwillingness to abstain from sexual intercourse with pregnant or lactating women or to use a condom and spermicide and another form of contraception (e.g., IUD, birth control pills taken by female partner, diaphragm with spermicide) if engaging in sexual intercourse with a woman who could become pregnant until discharge from the study and during 90 additional days.
- Subjects unlikely to co-operate in the study, and/or poor compliance anticipated by the investigator.
- Subject being in the exclusion period of a previous trial.
- Subject having exceeded the earnings for the last 12 months, including the indemnities for the present study.
- Subject who could not be contacted in case of emergency.
- Subject refusing to give written informed consent.
- Subject who has received blood or plasma derivatives in the year preceding the study.
- Subject who has given blood within the past 3 months or has planned to give blood or sperm within the 90 days following the study.
- Subject who has forfeited their freedom by administrative or legal award, or who is under guardianship or under limited judicial protection.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Eurofins|Optimed
Gières, 38610
Centre d'Investigation Clinique - Centre de Pharmacologie Clinique et d'Evaluations Thérapeutiques (CIC-CPCET)
Marseille, 13385
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Combined Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of IFB-088, in Healthy Volunteers
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)
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- 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
- Keywords
- First-In-Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IFB-088 (2.5-60.0mg) oral capsuleDrug
Also called verum
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
Placebo (2.5-60.mg) oral capsuleDrug
Also called placebo
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
IFB-088 (15.0-50.0mg) oral capsuleDrug
Also called verum
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.
Placebo oral (15.0-50.0mg) capsuleDrug
Also called placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Placebo oral (15.0-50.0mg) capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
modification in Concomitant medication(s) occuring during the study (if applicable)
Measured: 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)
Plasma samples are collected:
SAD phase - cohort 1 (one intake for daily administration): Day 1 at predose, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 24, 32 hours
SAD phase - cohort 2 to 6 (two intakes for daily administration): Day 1 at predose, 0.33, 0.66, 1, 2, 3, 4, 5, 12, 12.25, 12.5, 13, 14, 16, 18, 24, 32 hours
MAD phase (two intakes for daily administration): Day 1 and Day 14 at predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 17, 19 and 21h ; Day 2 (24 hours); Day 7 (predose, 1h and 2 h post dose); Day 15 (24, 30, 36 and 42 hours after Day 14); Day 16 (48, 60 hours after Day 14).
Measured: 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)
Plasma samples are collected:
SAD phase - cohort 1 (one intake for daily administration): Day 1 at predose, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 24, 32 hours
SAD phase - cohort 2 to 6 (two intakes for daily administration): Day 1 at predose, 0.33, 0.66, 1, 2, 3, 4, 5, 12, 12.25, 12.5, 13, 14, 16, 18, 24, 32 hours
MAD phase (two intakes for daily administration): Day 1 and Day 14 at predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 17, 19 and 21h ; Day 2 (24 hours); Day 7 (predose, 1h and 2 h post dose); Day 15 (24, 30, 36 and 42 hours after Day 14); Day 16 (48, 60 hours after Day 14).
Measured: Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)
Pharmacokinetic: Terminal Half-life (t1/2)
Plasma samples are collected:
SAD phase - cohort 1 (one intake for daily administration): Day 1 at predose, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 24, 32 hours
SAD phase - cohort 2 to 6 (two intakes for daily administration): Day 1 at predose, 0.33, 0.66, 1, 2, 3, 4, 5, 12, 12.25, 12.5, 13, 14, 16, 18, 24, 32 hours
MAD phase (two intakes for daily administration): Day 1 and Day 14 at predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 17, 19 and 21h ; Day 2 (24 hours); Day 7 (predose, 1h and 2 h post dose); Day 15 (24, 30, 36 and 42 hours after Day 14); Day 16 (48, 60 hours after Day 14).
Measured: 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)
Plasma samples are collected:
SAD phase - cohort 1 (one intake for daily administration): Day 1 at predose, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 24, 32 hours
SAD phase - cohort 2 to 6 (two intakes for daily administration): Day 1 at predose, 0.33, 0.66, 1, 2, 3, 4, 5, 12, 12.25, 12.5, 13, 14, 16, 18, 24, 32 hours
MAD phase (two intakes for daily administration): Day 1 and Day 14 at predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 17, 19 and 21h ; Day 2 (24 hours); Day 7 (predose, 1h and 2 h post dose); Day 15 (24, 30, 36 and 42 hours after Day 14); Day 16 (48, 60 hours after Day 14).
Measured: Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)
Pharmacokinetic: Apparent Volume of Distribution (Vd/F)
Plasma samples are collected:
SAD phase - cohort 1 (one intake for daily administration): Day 1 at predose, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 24, 32 hours
SAD phase - cohort 2 to 6 (two intakes for daily administration): Day 1 at predose, 0.33, 0.66, 1, 2, 3, 4, 5, 12, 12.25, 12.5, 13, 14, 16, 18, 24, 32 hours
MAD phase (two intakes for daily administration): Day 1 and Day 14 at predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 17, 19 and 21h ; Day 2 (24 hours); Day 7 (predose, 1h and 2 h post dose); Day 15 (24, 30, 36 and 42 hours after Day 14); Day 16 (48, 60 hours after Day 14).
Measured: Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)
Pharmacokinetic: Apparent Total Body Clearance (CL/F)
Plasma samples are collected:
SAD phase - cohort 1 (one intake for daily administration): Day 1 at predose, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 24, 32h
SAD phase - cohort 2 to 6 (two intakes for daily administration): Day 1 at predose, 0.33, 0.66, 1, 2, 3, 4, 5, 12, 12.25, 12.5, 13, 14, 16, 18, 24, 32h
MAD phase (two intakes for daily administration): Day 1 and Day 14 at predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 17, 19 and 21h ; Day 2 (24 hours); Day 7 (predose, 1h and 2 h post dose); Day 15 (24, 30, 36 and 42 hours after Day 14); Day 16 (48, 60 hours after Day 14).
Measured: Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)
Pharmacokinetic: Renal Clearance (CLr)
Urine samples are collected:
SAD phase - cohort 1 (one intake for daily administration): Day 1 at predose, 0-4 hours, 4-8 hours, 8-16 hours,16-32 hours SAD phase - cohort 2 to 6 (two intakes for daily administration): Day 1 at predose, 0-4, 4-8, 8-12, 12-24, 24-32 hours MAD phase (two intakes for daily administration): Day 1 and Day 14: predose, 0-4, 4-12, 12-24 hours; Day 6: predose, 0-4 and 4-12 hours; Day 15: 24-36, 36-48 hours after Day 14
Measured: Starting 1 hour prior to dosing on Day 1 and until 48 hours after last dosing (Day 16)
Pharmacokinetic: Percent of Drug Recovered in Urine (Ae %Dose)
Urine samples are collected:
SAD phase - cohort 1 (one intake for daily administration): Day 1 at predose, 0-4 hours, 4-8 hours, 8-16 hours,16-32 hours
SAD phase - cohort 2 to 6 (two intakes for daily administration): Day 1 at predose, 0-4, 4-8, 8-12, 12-24, 24-32 hours
MAD phase (two intakes for daily administration): Day 1 and Day 14: predose, 0-4, 4-12, 12-24 hours; Day 6: predose, 0-4 and 4-12 hours; Day 15: 24-36, 36-48 hours after Day 14
Measured: Starting 1 hour prior to dosing on Day 1 and until 48 hours after last dosing (Day 16)
Number of Participants With Clinically Significant Change in Physical Evaluation During the Study
the following parameters are assessed during the physical evaluation visit: Cardiovascular system (see specific outcome measure), Digestive system (included spleen organ), alcohol consumption (Ethylotest), General condition, Liver and biliary tracts, Lymphatic system, Muco-cutaneous system, Neck/Thyroide, Nervous system, ENTsystem, Respiratory system, Visual system
Measured: SAD & MAD phases: Screening; Day 2 (SAD) or Day 17 (MAD); and at End of study visit (7 to 14 days after last dosing)
Number of Participants With Clinically Significant Change in Physiological Parameters During the Study
Weight measured in kg and height measured in cm, were taken and Body Mass Index was calculated using those 2 values
Measured: SAD & MAD phases: Screening; Day 2 (SAD) or Day 17 (MAD); and at End of study visit (7 to 14 days after last dosing)
Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study
This safety outcome aims at monitoring cardiovascular functions and identify potential adverse events/reactions (clinical assessment combined with ECGs and vital signs assessments).
Measured: From screening visit until end of study visit (7 to 14 days after last dosing)
Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study
Tympanic body temperature will be measured at the time frame described underneath.at the following Timepoints :
change in body temperature (fever) will be reported per patient per group.
Measured: SAD phase (cohorts 1 to 6):Screening, Day -1;Day 1 ;end (7 to 14 days after last dosing) MAD phase: Screening;Day -1; Day 1 ;predose at Day 2, Day 4, Day 6, Day 8, Day 10, Day 12; Day 14 ; Day 17; end (7 to 14 days after last dosing)
Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study
This safety outcome aims at monitoring hematology parameters:
Red blood cell (RBC) count, hemoglobin, hematocrit, white blood cell (WBC) count (neutrophils, lymphocytes, monocytes, eosinophils, basophils), platelets, reticulocyte count will be monitored from screening to end of study visit (7 to 14 days after last dosing), at several time points.
When a participant experienced clinically significant change in the parameter, at least once during the study, he/she is recorded in the table.
Measured: SAD phase: Screening; Day -1; Day 2 (24 hours); end of study visit (7 to 14 days after last dosing) MAD phase: Screening; Day -1; predose, at Day 3, Day 6, Day 10, Day 13; Day 17; end of study visit (7 to 14 days after last dosing)
Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study
This safety outcome aims at monitoring coagulation parameters such as Activated partial thromboplastin time (APTT), international normalized ratio (INR)
Measured: SAD phase: Screening; Day -1; Day 2 (24 hours); end of study visit (7 to 14 days after last dosing) MAD phase: Screening; Day -1; predose at Day 3, Day 6, Day 10, Day ; Day 17; end of study visit (7 to 14 days after last dosing)
Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study
This safety outcome aims at monitoring the following blood biochemistry parameters:
Sodium, potassium, chloride, calcium, total bilirubin, alanine aminotransferase (ASAT), aspartate aminotransferase (ALAT), gamma-glutamyl transferase (GGT), alkaline phosphatases, total protein, albumin, urea, uric acid, bicarbonate, creatine phosphokinase (CPK), creatinine, glycaemia, lactate dehydrogenase (LDH), total cholesterol, HDL and LDL cholesterol, triglycerides
Measured: SAD phase: Screening; Day -1; Day 2 (24 hours); end of study visit (7 to 14 days after last dosing) MAD phase: Screening; Day -1; predose at Day 3, Day 6, Day 10, Day 13; Day 17; end of study visit (7 to 14 days after last dosing)
Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study
This safety outcome aims at monitoring urinary functions/parameters:
Specific gravity, pH, glucose, protein, blood, nitrites, leucocytes and ketones by dipstick.
Results are given as "absent" or "present, not clinically significant" or "present clinically significant".
A cytobacteriological exam will be done if abnormal results on dipstick). Beta 2 microglobulin (B2M), proteinuria and creatinuria will be also monitored.
Measured: SAD phase: Screening; Day -1; Day 1 (predose, 12, 24, 32 hours); end of study visit (7 to 14 days after last dosing) MAD phase: Screening; Day -1; predose at Day 1, Day 3, Day 6, Day 10, Day 13; Day 17; end of study visit (7 to 14 days after last dosing)
Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study
Assessment and monitoring of the vigilance/mood of healthy volunteers through the use of a Bond-Lader Visual Analogue Scale listing 16 mood items, with 2 words at the beginning and the end of the scale bar. Depending on the item, the scale would go from better to worse (ie strong to weak) or the opposite (Hostile to friendly). Alertness, Self-contentment, Calmness are computed by averaging their respective items and are mentionned in the volunteer file.
Measured: SAD Phase: Screening; Day 1 (predose, 1.5, 12, 32 hours) MAD Phase: Screening; Day 1 (predose, 1.5, 12 hours); Day 14 (predose, 1.5, 12 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start21 Jun 2018
- Primary completion21 Jun 2019
- Study completion16 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind, randomized, placebo-controlled, combined single and multiple ascending dose of IFB-088 by successive cohorts study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- InFlectis BioScience
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Qualissima, Assistance Publique Hopitaux De Marseille, Stragen France, Eurofins Optimed
- Responsible party
- Sponsor
- Investigators
- Christine Audebert, MD, Principal investigator, APHM - Centre de Pharmacolgie Clinique et d'Evaluations Thérapeutiques
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610334
- Sponsor's protocol ID
- P188
- Other IDs
- 2018-000443-29, 2018
- Status last verified
- Nov 2021
- First submitted
- 20 Jun 2018
- Last updated
- 26 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Combined Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of IFB-088, in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03610334
- Acronym / sponsor ID
- P188
- Conditions
- Healthy Volunteers
- Keywords
- First-In-Human
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- InFlectis BioScienceIndustry (pharma, biotech, devices)
- Collaborators
- Qualissima, Assistance Publique Hopitaux De Marseille, Stragen France, Eurofins Optimed
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Posted 26 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 18
- Model description
- double-blind, randomized, placebo-controlled, combined single and multiple ascending dose of IFB-088 by successive cohorts study
| Arm | Type | Receives |
|---|---|---|
| SAD IFB-088 2.5mg | Experimental | Drug: IFB-088 (2.5-60.0mg) oral capsuleCohort 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 |
| SAD Placebo 2.5mg | Placebo comparator | Drug: Placebo (2.5-60.mg) oral capsuleCohort 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 |
| SAD IFB-088 5.0mg | Experimental | Drug: IFB-088 (2.5-60.0mg) oral capsuleCohort 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 |
| SAD Placebo 5.0mg | Placebo comparator | Drug: Placebo (2.5-60.mg) oral capsuleCohort 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 |
| SAD IFB-088 10.0mg | Experimental | Drug: IFB-088 (2.5-60.0mg) oral capsuleCohort 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 |
| SAD Placebo 10.0mg | Placebo comparator | Drug: Placebo (2.5-60.mg) oral capsuleCohort 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 |
| SAD IFB-088 20.0mg | Experimental | Drug: IFB-088 (2.5-60.0mg) oral capsuleCohort 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 |
| SAD Placebo 20.0mg | Placebo comparator | Drug: Placebo (2.5-60.mg) oral capsuleCohort 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 |
| SAD IFB-088 40.0mg | Experimental | Drug: IFB-088 (2.5-60.0mg) oral capsuleCohort 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 |
| SAD Placebo 40.0mg | Placebo comparator | Drug: Placebo (2.5-60.mg) oral capsuleCohort 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 |
| SAD IFB-088 60.0mg | Experimental | Drug: IFB-088 (2.5-60.0mg) oral capsuleCohort 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 |
| SAD Placebo 60.0mg | Experimental | Drug: Placebo (2.5-60.mg) oral capsuleCohort 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 |
| MAD IFB-088 15 mg | Experimental | Drug: IFB-088 (15.0-50.0mg) oral capsuleCohort 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. |
| MAD Placebo 15 mg | Placebo comparator | Drug: Placebo oral (15.0-50.0mg) capsuleCohort 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. |
| MAD IFB-088 30 mg | Experimental | Drug: IFB-088 (15.0-50.0mg) oral capsuleCohort 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. |
| MAD Placebo 30 mg | Placebo comparator | Drug: Placebo oral (15.0-50.0mg) capsuleCohort 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. |
| MAD IFB-088 50 mg | Experimental | Drug: IFB-088 (15.0-50.0mg) oral capsuleCohort 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. |
| MAD Placebo 50 mg | Placebo comparator | Drug: Placebo oral (15.0-50.0mg) capsuleCohort 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (27 listed)
- 1. 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IFB-088 (2.5-60.0mg) oral capsuleAlso: verumSAD 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 | 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 capsuleAlso: placeboSAD 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 | 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 capsuleAlso: verumMAD 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 | MAD IFB-088 15 mg, MAD IFB-088 30 mg, MAD IFB-088 50 mg |
| Placebo oral (15.0-50.0mg) capsuleAlso: placeboMAD 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. | Drug | MAD Placebo 15 mg, MAD Placebo 30 mg, MAD Placebo 50 mg |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events Per Group
Time frame: SAD & MAD phases: Screening visit to End of study visit (7 to 14 days after last dosing) + 30 days
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.
18 secondary outcomes
Number of Participants With Change in Concomitant Medications
Time frame: 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)
Time frame: 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)
Time frame: Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)
Pharmacokinetic: Terminal Half-life (t1/2)
Time frame: 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)
Time frame: Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)
Pharmacokinetic: Apparent Volume of Distribution (Vd/F)
Time frame: Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)
Pharmacokinetic: Apparent Total Body Clearance (CL/F)
Time frame: Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)
Pharmacokinetic: Renal Clearance (CLr)
Time frame: Starting 1 hour prior to dosing on Day 1 and until 48 hours after last dosing (Day 16)
Pharmacokinetic: Percent of Drug Recovered in Urine (Ae %Dose)
Time frame: Starting 1 hour prior to dosing on Day 1 and until 48 hours after last dosing (Day 16)
Number of Participants With Clinically Significant Change in Physical Evaluation During the Study
Time frame: SAD & MAD phases: Screening; Day 2 (SAD) or Day 17 (MAD); and at End of study visit (7 to 14 days after last dosing)
Number of Participants With Clinically Significant Change in Physiological Parameters During the Study
Time frame: SAD & MAD phases: Screening; Day 2 (SAD) or Day 17 (MAD); and at End of study visit (7 to 14 days after last dosing)
Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study
Time frame: From screening visit until end of study visit (7 to 14 days after last dosing)
Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study
Time frame: SAD phase (cohorts 1 to 6):Screening, Day -1;Day 1 ;end (7 to 14 days after last dosing) MAD phase: Screening;Day -1; Day 1 ;predose at Day 2, Day 4, Day 6, Day 8, Day 10, Day 12; Day 14 ; Day 17; end (7 to 14 days after last dosing)
Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study
Time frame: SAD phase: Screening; Day -1; Day 2 (24 hours); end of study visit (7 to 14 days after last dosing) MAD phase: Screening; Day -1; predose, at Day 3, Day 6, Day 10, Day 13; Day 17; end of study visit (7 to 14 days after last dosing)
Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study
Time frame: SAD phase: Screening; Day -1; Day 2 (24 hours); end of study visit (7 to 14 days after last dosing) MAD phase: Screening; Day -1; predose at Day 3, Day 6, Day 10, Day ; Day 17; end of study visit (7 to 14 days after last dosing)
Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study
Time frame: SAD phase: Screening; Day -1; Day 2 (24 hours); end of study visit (7 to 14 days after last dosing) MAD phase: Screening; Day -1; predose at Day 3, Day 6, Day 10, Day 13; Day 17; end of study visit (7 to 14 days after last dosing)
Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study
Time frame: SAD phase: Screening; Day -1; Day 1 (predose, 12, 24, 32 hours); end of study visit (7 to 14 days after last dosing) MAD phase: Screening; Day -1; predose at Day 1, Day 3, Day 6, Day 10, Day 13; Day 17; end of study visit (7 to 14 days after last dosing)
Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study
Time frame: SAD Phase: Screening; Day 1 (predose, 1.5, 12, 32 hours) MAD Phase: Screening; Day 1 (predose, 1.5, 12 hours); Day 14 (predose, 1.5, 12 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Website of InFlectis BioScienceLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Audebert, MD principal investigator
APHM - Centre de Pharmacolgie Clinique et d'Evaluations Thérapeutiques
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IFB-088 (2.5-60.0mg) oral capsule and IFB-088 (15.0-50.0mg) oral capsule in people with Healthy Volunteers, run by InFlectis BioScience at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events Per Group (time frame: SAD & MAD phases: Screening visit to End of study visit (7 to 14 days after last dosing) + 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2022.