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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000443-29 | EudraCT Number |
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| Name | Class |
|---|---|
| Qualissima | OTHER |
| Assistance Publique Hopitaux De Marseille | OTHER |
| Stragen France | INDUSTRY |
| Eurofins Optimed |
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
|
| 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 |
|
| 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 |
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| SAD IFB-088 10.0mg | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Change in Concomitant Medications | modification in Concomitant medication(s) occuring during the study (if applicable) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| SAD Exploratory Biomarkers Analysis | Blood samples will be collected and stored in a biobank to explore potential biomarkers that remain to be identified | SAD phase: Day 1 at predose, 1.5 hours and 24 hours |
| MAD Exploratory Biomarkers Analysis |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Audebert, MD | APHM - Centre de Pharmacolgie Clinique et d'Evaluations Thérapeutiques | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurofins|Optimed | Gières | 38610 | France | |||
| Centre d'Investigation Clinique - Centre de Pharmacologie Clinique et d'Evaluations Thérapeutiques (CIC-CPCET) |
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| Label | URL |
|---|---|
| Website of InFlectis BioScience | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | SAD IFB-088 2.5 mg | A single daily dose of IFB-088 2.5 mg is administered to 6 healthy volunteers |
| FG001 | SAD Placebo 2.5mg | A single daily dose of placebo (microcristalline cellusose) 2.5 mg is administered to 2 healthy volunteers |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1: 2.5mg (1 Day) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 6, 2019 |
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| INDUSTRY |
double-blind, randomized, placebo-controlled, combined single and multiple ascending dose of IFB-088 by successive cohorts study
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Capsules used for verum or placebo (Size 5 white opaque HPMC capsule) are identical and equally-weighted
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 |
|
| 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 |
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| 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 |
|
| 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 |
|
| 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 |
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| 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 |
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| 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 |
|
| 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 |
|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
|
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| 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 |
|
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| 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. |
|
|
| 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. |
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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). |
| 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). | 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). | 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). | 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). | 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). | 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 | 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 | 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 | 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 | 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). | 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. | 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. | 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) | 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 | 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. | 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. | 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) |
Blood samples will be collected and stored in a biobank to explore potential biomarkers that remain to be identified
| MAD phase: Day 1 and Day 14 at predose, 1.5 hours and 24 hours |
| Marseille |
| 13385 |
| France |
| FG002 | SAD IFB-088 5.0mg | Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the previous period. A single daily dose of IFB-088 5.0 mg is administered to 6 healthy volunteers, in two intakes of 2.5mg, separated by 12h. |
| FG003 | SAD Placebo 5.0mg | Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the previous period. A single daily dose of placebo (microcrystalline cellulose) 5.0 mg is administered to 2 healthy volunteers, in two intakes of 2.5mg, separated by 12h. |
| FG004 | SAD IFB-088 10.0mg | Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the previous period. A single daily dose of IFB-088 10.0 mg is administered to 6 healthy volunteers, in two intakes of 5.0mg, separated by 12h. |
| FG005 | SAD Placebo 10.0mg | Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the previous period. A single daily dose of placebo (microcrystalline cellusose) 10.0 mg is administered to 2 healthy volunteers, in two intakes of 5.0mg, separated by 12h. |
| FG006 | SAD IFB-088 20.0mg | Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the previous period. A single daily dose of IFB-088 20.0 mg is administered to 6 healthy volunteers, in two intakes of 10.0mg, separated by 12h. |
| FG007 | SAD Placebo 20.0mg | Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the previous period. A single daily dose of placebo (microcrystalline cellusose) 20.0 mg is administered to 2 healthy volunteers, in two intakes of 10.0mg, separated by 12h. |
| FG008 | SAD IFB-088 40.0mg | Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the previous period. A single daily dose of IFB-088 40.0 mg is administered to 6 healthy volunteers, in two intakes of 20.mg, separated by 12h. |
| FG009 | SAD Placebo 40.0mg | Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the previous period. A single daily dose of placebo (microcrystalline cellusose) 40.0 mg is administered to 2 healthy volunteers, in two intakes of 20.0mg, separated by 12h. |
| FG010 | SAD IFB-088 60.0mg | Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the previous period. A single daily dose of IFB-088 60.0 mg is administered to 6 healthy volunteers, in two intakes of 30.0mg, separated by 12h. |
| FG011 | SAD Placebo 60.0mg | Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the previous period. A single daily dose of placebo (microcrystalline cellusose) 60.0 mg is administered to 2 healthy volunteers, in two intakes of 30.0mg, separated by 12h. |
| FG012 | MAD IFB-088 15.0mg | Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the Single Ascending Dose Study. A single dose of IFB-088 15.0 mg is administered to 6 healthy volunteers, during 14 days |
| FG013 | MAD Placebo 15.0mg | Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the Single Ascending Dose Study. A single dose of placebo (microcrystalline cellulose) 15.0 mg is administered to 2 healthy volunteers, during 14 days |
| FG014 | MAD IFB-088 30.0mg | Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the previous period. A dose of IFB-088 30.0 mg is administered in two intakes of 15.0mg, administered at 12hours of interval, to 6 healthy volunteers, during 14 days. |
| FG015 | MAD Placebo 30.0mg | Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the previous period. A dose of placebo (microcrystalline cellulose) 30.0 mg is administered in two intakes of 15.0mg, administered at 12hours of interval, to 2 healthy volunteers, during 14 days. |
| FG016 | MAD IFB-088 50.0mg | Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the previous period. A dose of IFB-088 50.0 mg is administered in two intakes of 25.0mg, administered at 12hours of interval, to 6 healthy volunteers, during 14 days. |
| FG017 | MAD Placebo 50.0mg | Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the previous period. A dose of placebo (microcrystalline cellulose) 50.0 mg is administered in two intakes of 25.0mg, administered at 12hours of interval, to 2 healthy volunteers, during 14 days. |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2: 5.0mg (1 Day) |
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| Period 3: 10.0mg (1 Day) |
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| Period 4: 20.0mg (1 Day) |
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| Period 5: 40.0mg (1 Day) |
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| Period 6: 60.0mg (1 Day) |
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| Period 7: 15.0mg (Day 1 to 14) |
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| Period 8: 30.0mg (Day 1 to 14) |
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| Period 9: 50.0mg (Day 1 to 14) |
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the trial is divided into 2 phases (SAD and MAD). SAD included a total of 6 cohorts (total of 48 volunteers), with 36 (6x6) volunteers receiving the verum at dose ranging from 2.5mg to 60.0mg/day, and 12 (6x2) receiving the equivalent placebo. MAD included a total of 3 cohorts (total of 24 volunteeres), with 18 (3x6) receiving the verum at dose ranging from 15 to 50mg/day, and 6 (3x2) receiving the equivalent placebo for 14 days.
All patients were healthy French caucasian male above 18 years.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: SAD IFB-088 2.5mg | a single daily dose of 2.5mg IFB-088 in oral capsule, is administered in the morning (8:00am), in one intake |
| BG001 | Cohort 2: SAD IFB-088 5.0mg | a single daily dose of 5.0mg IFB-088 in oral capsule, divided into 2 doses of 2.5mg, is administered, separated by an interval of 12h (in the morning (8:00am), and in the evening (8:00pm) |
| BG002 | Cohort 3: SAD IFB-088 10.0mg | a single daily dose of 10.0mg IFB-088 in oral capsule, divided into 2 doses of 5.0mg, is administered, separated by an interval of 12h (in the morning (8:00am), and in the evening (8:00pm) |
| BG003 | Cohort 4: SAD IFB-088 20.0mg | a single daily dose of 20.0mg IFB-088 in oral capsule, divided into 2 doses of 10.0mg, is administered, separated by an interval of 12h (in the morning (8:00am), and in the evening (8:00pm) |
| BG004 | Cohort 5: SAD IFB-088 40.0mg | a single daily dose of 40.0mg IFB-088 in oral capsule, divided into 2 doses of 20.0mg, is administered, separated by an interval of 12h (in the morning (8:00am), and in the evening (8:00pm) |
| BG005 | Cohort 6: SAD IFB-088 60.0mg | a single daily dose of 60.0mg IFB-088 in oral capsule, divided into 2 doses of 30.0mg, is administered, separated by an interval of 12h (in the morning (8:00am), and in the evening (8:00pm) |
| BG006 | Cohort 7: MAD IFB-088 15.0mg | subject taking 15.0mg of IFB-088 in oral capsule, divided into 2 doses of 7.5mg, separated by an interval of 12 hours, in the morning (8:00am), and in the evening (8:00pm), for 14 days |
| BG007 | Cohort 8: MAD IFB-088 30.0mg | subject taking 30.0mg of IFB-088 in oral capsule, divided into 2 doses of 15.0mg, separated by an interval of 12 hours, in the morning (8:00am), and in the evening (8:00pm), for 14 days |
| BG008 | Cohort 9: MAD IFB-088 50.0mg | subject taking 50.0mg of IFB-088 in oral capsule, divided into 2 doses of 25.0mg, separated by an interval of 12 hours, in the morning (8:00am), and in the evening (8:00pm), for 14 days |
| BG009 | SAD Placebo Group | a single daily dose of placebo in oral capsule, divided into 1 or 2 doses equivalent to verum, is administered, separated by an interval of 12h (in the morning (8:00am), and in the evening (8:00pm) |
| BG010 | MAD Placebo Group | subject taking placebo equivalent to the verum dose in oral capsule, divided into 2 doses , separated by an interval of 12 hours, in the morning (8:00am), and in the evening (8:00pm), for 14 days |
| BG011 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 2 parts: SAD: 48 subjects and MAD: 24 subjects | Mean | Full Range | Year |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | 72 Healthy volunteers included in the study, from inclusion visit, up to study disclosure visit, were followed for TEAE. As this this study was a first in human dose escalating study, if TEAE occured in a group, they were analysed by an independant safety commity as not related, unlikely related or possibly related to the study drug, to evaluate safety of the drug and allow to raise the dose in the next group. | Posted | Count of Participants | Participants | SAD & MAD phases: Screening visit to End of study visit (7 to 14 days after last dosing) + 30 days |
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| Secondary | Number of Participants With Change in Concomitant Medications | modification in Concomitant medication(s) occuring during the study (if applicable) | Posted | Count of Participants | Participants | SAD & MAD phases: Continuous (Screening visit to End of study visit (7 to 14 days after last dosing) + 30 days) |
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| Secondary | 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). | 6 patients per cohort have received the verum and are presented. In all groups but one, patients received the verum twice daily. Cmax has hence been measured twice. In the SAD IFB-088 2.5mg cohort, 0 patient received dose 2 as only 1 dose (dose 1) of 2.5mg was given to the patient therefore Cmax Dose 2 has not been measured. | Posted | Mean | Standard Deviation | ng/ml | Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17) |
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| Secondary | 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). | 6 patients per cohort have received the verum and are presented. In all groups but one, patients received the verum twice daily. Tmax has hence been measured twice. In the SAD IFB-088 2.5mg cohort, 0 patient received dose 2 as only 1 dose (dose 1) of 2.5mg was given to the patient therefore Tmax Dose 2 has not been measured. | Posted | Median | Inter-Quartile Range | h | Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17) |
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| Secondary | 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). | Posted | Mean | Standard Deviation | h | Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17) |
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| Secondary | 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). | Posted | Mean | Standard Deviation | ng*h/mL | Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17) |
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| Secondary | 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). | 6 patients per cohort have received the verum and are presented. In all groups but one (SAD IFB-088 2.5mg), patients received the verum twice daily. Data were not collected for the SAD IFB-088 2.5 and 5.0mg cohorts | Posted | Mean | Standard Deviation | L | Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17) |
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| Secondary | 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). | 6 patients per cohort have received the verum and are presented. In all groups but one (SAD IFB-088 2.5mg), patients received the verum twice daily. Data were not collected for the SAD IFB-088 2.5 and 5.0mg cohorts | Posted | Mean | Standard Deviation | L/h | Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17) |
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| Secondary | 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 | Data were not collected for the SAD IFB-088 2.5 mg cohort | Posted | Mean | Standard Deviation | mL/min | Starting 1 hour prior to dosing on Day 1 and until 48 hours after last dosing (Day 16) |
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| Secondary | 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 | 6 patients per cohort have received the verum and are presented. In all groups but one (SAD IFB-088 2.5mg), patients received the verum twice daily. Data were not collected for the SAD IFB-088 2.5 cohort | Posted | Mean | Standard Deviation | mg/day | Starting 1 hour prior to dosing on Day 1 and until 48 hours after last dosing (Day 16) |
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| Secondary | 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 | Posted | Count of Participants | Participants | SAD & MAD phases: Screening; Day 2 (SAD) or Day 17 (MAD); and at End of study visit (7 to 14 days after last dosing) |
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| Secondary | 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 | Posted | Count of Participants | Participants | SAD & MAD phases: Screening; Day 2 (SAD) or Day 17 (MAD); and at End of study visit (7 to 14 days after last dosing) |
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| Secondary | 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). | Posted | Count of Participants | Participants | From screening visit until end of study visit (7 to 14 days after last dosing) |
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| Secondary | 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. | Posted | Count of Participants | Participants | 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) |
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| Secondary | 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. | Posted | Count of Participants | Participants | 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) |
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| Secondary | 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) | Posted | Count of Participants | Participants | 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) |
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| Secondary | 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 | Posted | Count of Participants | Participants | 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) |
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| Secondary | 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. | Posted | Count of Participants | Participants | 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) |
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| Secondary | 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. | Posted | Count of Participants | Participants | 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) |
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| Other Pre-specified | SAD Exploratory Biomarkers Analysis | Blood samples will be collected and stored in a biobank to explore potential biomarkers that remain to be identified | Not Posted | SAD phase: Day 1 at predose, 1.5 hours and 24 hours | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | MAD Exploratory Biomarkers Analysis | Blood samples will be collected and stored in a biobank to explore potential biomarkers that remain to be identified | Not Posted | MAD phase: Day 1 and Day 14 at predose, 1.5 hours and 24 hours | Participants |
18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SAD IFB-088 2.5mg | cohort 1: single daily dose of 2.5mg IFB-088 oral capsule, administered in the morning (8:00am), in one intake | 0 | 6 | 0 | 6 | 1 | 6 |
| EG001 | SAD IFB-088 5.0mg | cohort 2: single daily dose of 5.0mg IFB-088 oral capsule, administered in two intakes of 2.5mg, 12 hours apart, in the morning (8:00am), and in the evening (8:00pm) | 0 | 6 | 0 | 6 | 1 | 6 |
| EG002 | SAD IFB-088 10.0mg | cohort 3: single daily dose of 10.0mg IFB-088 oral capsule, administered in two intakes of 5.0mg, 12 hours apart, in the morning (8:00am), and in the evening (8:00pm) | 0 | 6 | 0 | 6 | 2 | 6 |
| EG003 | SAD IFB-088 20.0mg | cohort 4: single daily dose of 20.0mg IFB-088 oral capsule, administered in two intakes of 10.0mg, 12 hours apart, in the morning (8:00am), and in the evening (8:00pm) | 0 | 6 | 0 | 6 | 2 | 6 |
| EG004 | SAD IFB-088 40.0mg | cohort 5: single daily dose of 40.0mg IFB-088 oral capsule, administered in two intakes of 20.0mg, 12 hours apart, in the morning (8:00am), and in the evening (8:00pm) | 0 | 6 | 0 | 6 | 2 | 6 |
| EG005 | SAD IFB-088 60.0mg | cohort 6: single daily dose of 60.0mg IFB-088 oral capsule, administered in two intakes of 30.0mg, 12 hours apart, in the morning (8:00am), and in the evening (8:00pm) | 0 | 6 | 0 | 6 | 3 | 6 |
| EG006 | SAD Placebo | (cohort 1 to 6): single daily dose of placebo oral capsule, administered in two intakes (except for the first SAD dose that is administered in one intake), at 12h intervals, in the morning (8:00am) and in the evening (8:00pm) | 0 | 12 | 0 | 12 | 2 | 12 |
| EG007 | MAD IFB-088 15.0mg | cohort 7: subject taking 15.0mg of IFB-088 oral capsule divided in two dose of 7.5mg, at an interval of 12h, in the morning (8:00am), and in the evening (8:00pm), for 14 days. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG008 | MAD IFB-088 30.0mg | cohort 8: subject taking 30.0mg of IFB-088 oral capsule divided in two dose of 15.0mg, at an interval of 12h, in the morning (8:00am), and in the evening (8:00pm), for 14 days. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG009 | MAD IFB-088 50.0mg | cohort 9: subject taking 50.0mg of IFB-088 oral capsule divided in two dose of 25.0mg, at an interval of 12h, in the morning (8:00am), and in the evening (8:00pm), for 14 days. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG010 | MAD Placebo | (cohort 7 to 9): subject taking placebo oral capsule divided in two doses, at an interval of 12h, in the morning (8:00am), and in the evning (8:00pm), for 14 days. | 0 | 6 | 0 | 6 | 2 | 6 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
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| pyrexia | General disorders | MedDRA (21.0) | Systematic Assessment |
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| catheter site related reaction | General disorders | MedDRA (21.0) | Systematic Assessment |
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| hypertriglyceridemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
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| influenza like illness | General disorders | MedDRA (21.0) | Systematic Assessment |
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| nasopharyngitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
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| toothache | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
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| joint injury | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
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| diarrhoea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
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| rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
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| ear pain | Ear and labyrinth disorders | MedDRA (21.0) | Systematic Assessment |
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| orthostatic hypotension | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
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| nephrolithiasis | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
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| haematuria | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
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| pollakyuria | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
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| nausea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
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| paraesthesia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
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| abdominal pain | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
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| presyncope | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
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The disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Anne Visbecq (Chief Medical Officer) | Inflectis Bioscience | 0630632020 | 33 | annevisbecq@inflectisbioscience.com |
| Jan 5, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| C068637 | calcium D-pantothenate, L-cysteine drug combination |
Not provided
Not provided
Not provided
| Male |
|
healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval. |
| OG005 | SAD Placebo 10.0mg | healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval. |
| OG006 | SAD IFB-088 20.0mg | healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval. |
| OG007 | SAD Placebo 20.0mg | healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval. |
| OG008 | SAD IFB-088 40.0mg | healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval. |
| OG009 | SAD Placebo 40.0mg | healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval. |
| OG010 | SAD IFB-088 60.0mg | healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval. |
| OG011 | SAD Placebo 60.0mg | healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval. |
| OG012 | MAD IFB-088 15.0mg | healthy volunteers received IFB-088 15.0mg daily, in the morning, during 14 days. |
| OG013 | MAD Placebo 15.0mg | healthy volunteers received placebo 15.0mg daily, in the morning, during 14 days. |
| OG014 | MAD IFB-088 30.0mg | healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days. |
| OG015 | MAD Placebo 30.0mg | healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days. |
| OG016 | MAD IFB-088 50.0mg | healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days. |
| OG017 | MAD Placebo 50.0mg | healthy volunteers received placebo 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days. |
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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 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 |
| OG002 | SAD IFB-088 10.0mg | 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 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 |
| OG003 | SAD IFB-088 20.0mg | 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 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 |
| OG004 | SAD IFB-088 40.0mg | 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 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 |
| OG005 | SAD IFB-088 60.0mg | 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 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 |
| OG006 | MAD IFB-088 15.0mg | 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. 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. |
| OG007 | MAD IFB-088 30.0mg | 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. 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. |
| OG008 | MAD IFB-088 50.0mg | 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. 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. |
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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 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 |
| OG002 | SAD IFB-088 10.0mg | 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 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 |
| OG003 | SAD IFB-088 20.0mg | 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 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 |
| OG004 | SAD IFB-088 40.0mg | 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 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 |
| OG005 | SAD IFB-088 60.0mg | 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 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 |
| OG006 | MAD IFB-088 15 mg | 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. 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. |
| OG007 | MAD IFB-088 30 mg | 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. 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. |
| OG008 | MAD IFB-088 50 mg | 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. 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. |
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| OG002 | SAD IFB-088 10.0mg | 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 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 |
| OG003 | SAD IFB-088 20.0mg | 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 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 |
| OG004 | SAD IFB-088 40.0mg | 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 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 |
| OG005 | SAD IFB-088 60.0mg | 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 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 |
| OG006 | MAD IFB-088 15 mg | 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. 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. |
| OG007 | MAD IFB-088 30 mg | 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. 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. |
| OG008 | MAD IFB-088 50 mg | 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. 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. |
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| OG002 | SAD IFB-088 10.0mg | 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 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 |
| OG003 | SAD IFB-088 20.0mg | 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 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 |
| OG004 | SAD IFB-088 40.0mg | 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 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 |
| OG005 | SAD IFB-088 60.0mg | 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 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 |
| OG006 | MAD IFB-088 15 mg | 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. 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. |
| OG007 | MAD IFB-088 30 mg | 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. 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. |
| OG008 | MAD IFB-088 50 mg | 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. 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. |
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| OG002 | SAD IFB-088 10.0mg | 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 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 |
| OG003 | SAD IFB-088 20.0mg | 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 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 |
| OG004 | SAD IFB-088 40.0mg | 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 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 |
| OG005 | SAD IFB-088 60.0mg | 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 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 |
| OG006 | MAD IFB-088 15 mg | 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. 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. |
| OG007 | MAD IFB-088 30 mg | 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. 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. |
| OG008 | MAD IFB-088 50 mg | 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. 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. |
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| OG002 | SAD IFB-088 10.0mg | 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 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 |
| OG003 | SAD IFB-088 20.0mg | 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 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 |
| OG004 | SAD IFB-088 40.0mg | 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 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 |
| OG005 | SAD IFB-088 60.0mg | 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 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 |
| OG006 | MAD IFB-088 15 mg | 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. 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. |
| OG007 | MAD IFB-088 30 mg | 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. 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. |
| OG008 | MAD IFB-088 50 mg | 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. 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. |
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| OG002 | SAD IFB-088 10.0mg | 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 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 |
| OG003 | SAD IFB-088 20.0mg | 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 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 |
| OG004 | SAD IFB-088 40.0mg | 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 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 |
| OG005 | SAD IFB-088 60.0mg | 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 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 |
| OG006 | MAD IFB-088 15 mg | 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. 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. |
| OG007 | MAD IFB-088 30 mg | 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. 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. |
| OG008 | MAD IFB-088 50 mg | 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. 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. |
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| OG002 | SAD IFB-088 10.0mg | 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 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 |
| OG003 | SAD IFB-088 20.0mg | 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 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 |
| OG004 | SAD IFB-088 40.0mg | 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 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 |
| OG005 | SAD IFB-088 60.0mg | 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 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 |
| OG006 | MAD IFB-088 15 mg | 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. 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. |
| OG007 | MAD IFB-088 30 mg | 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. 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. |
| OG008 | MAD IFB-088 50 mg | 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. 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. |
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healthy volunteers received placebo 5.0mg once daily, in two doses of 2.5mg, separated by a 12h interval.
| OG004 | SAD IFB-088 10.0mg | healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval. |
| OG005 | SAD Placebo 10.0mg | healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval. |
| OG006 | SAD IFB-088 20.0mg | healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval. |
| OG007 | SAD Placebo 20.0mg | healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval. |
| OG008 | SAD IFB-088 40.0mg | healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval. |
| OG009 | SAD Placebo 40.0mg | healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval. |
| OG010 | SAD IFB-088 60.0mg | healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval. |
| OG011 | SAD Placebo 60.0mg | healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval. |
| OG012 | MAD IFB-088 15.0mg | healthy volunteers received IFB-088 15.0mg daily, in the morning, during 14 days. |
| OG013 | MAD Placebo 15.0mg | healthy volunteers received placebo 15.0mg daily, in the morning, during 14 days. |
| OG014 | MAD IFB-088 30.0mg | healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days. |
| OG015 | MAD Placebo 30.0mg | healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days. |
| OG016 | MAD IFB-088 50.0mg | healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days. |
| OG017 | MAD Placebo 50.0mg | healthy volunteers received placebo 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days. |
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| SAD IFB-088 10.0mg |
healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval. |
| OG005 | SAD Placebo 10.0mg | healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval. |
| OG006 | SAD IFB-088 20.0mg | healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval. |
| OG007 | SAD Placebo 20.0mg | healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval. |
| OG008 | SAD IFB-088 40.0mg | healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval. |
| OG009 | SAD Placebo 40.0mg | healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval. |
| OG010 | SAD IFB-088 60.0mg | healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval. |
| OG011 | SAD Placebo 60.0mg | healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval. |
| OG012 | MAD IFB-088 15.0mg | healthy volunteers received IFB-088 15.0mg daily, in the morning, during 14 days. |
| OG013 | MAD Placebo 15.0mg | healthy volunteers received placebo 15.0mg daily, in the morning, during 14 days. |
| OG014 | MAD IFB-088 30.0mg | healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days. |
| OG015 | MAD Placebo 30.0mg | healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days. |
| OG016 | MAD IFB-088 50.0mg | healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days. |
| OG017 | MAD Placebo 50.0mg | healthy volunteers received placebo 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days. |
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| OG004 |
| SAD IFB-088 10.0mg |
healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval. |
| OG005 | SAD Placebo 10.0mg | healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval. |
| OG006 | SAD IFB-088 20.0mg | healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval. |
| OG007 | SAD Placebo 20.0mg | healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval. |
| OG008 | SAD IFB-088 40.0mg | healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval. |
| OG009 | SAD Placebo 40.0mg | healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval. |
| OG010 | SAD IFB-088 60.0mg | healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval. |
| OG011 | SAD Placebo 60.0mg | healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval. |
| OG012 | MAD IFB-088 15.0mg | healthy volunteers received IFB-088 15.0mg daily, in the morning, during 14 days. |
| OG013 | MAD Placebo 15.0mg | healthy volunteers received placebo 15.0mg daily, in the morning, during 14 days. |
| OG014 | MAD IFB-088 30.0mg | healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days. |
| OG015 | MAD Placebo 30.0mg | healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days. |
| OG016 | MAD IFB-088 50.0mg | healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days. |
| OG017 | MAD Placebo 50.0mg | healthy volunteers received placebo 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days. |
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| OG004 | SAD IFB-088 10.0mg | healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval. |
| OG005 | SAD Placebo 10.0mg | healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval. |
| OG006 | SAD IFB-088 20.0mg | healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval. |
| OG007 | SAD Placebo 20.0mg | healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval. |
| OG008 | SAD IFB-088 40.0mg | healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval. |
| OG009 | SAD Placebo 40.0mg | healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval. |
| OG010 | SAD IFB-088 60.0mg | healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval. |
| OG011 | SAD Placebo 60.0mg | healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval. |
| OG012 | MAD IFB-088 15.0mg | healthy volunteers received IFB-088 15.0mg daily, in the morning, during 14 days. |
| OG013 | MAD Placebo 15.0mg | healthy volunteers received placebo 15.0mg daily, in the morning, during 14 days. |
| OG014 | MAD IFB-088 30.0mg | healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days. |
| OG015 | MAD Placebo 30.0mg | healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days. |
| OG016 | MAD IFB-088 50.0mg | healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days. |
| OG017 | MAD Placebo 50.0mg | healthy volunteers received placebo 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days. |
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| OG003 | SAD Placebo 5.0mg | healthy volunteers received placebo 5.0mg once daily, in two doses of 2.5mg, separated by a 12h interval. |
| OG004 | SAD IFB-088 10.0mg | healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval. |
| OG005 | SAD Placebo 10.0mg | healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval. |
| OG006 | SAD IFB-088 20.0mg | healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval. |
| OG007 | SAD Placebo 20.0mg | healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval. |
| OG008 | SAD IFB-088 40.0mg | healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval. |
| OG009 | SAD Placebo 40.0mg | healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval. |
| OG010 | SAD IFB-088 60.0mg | healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval. |
| OG011 | SAD Placebo 60.0mg | healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval. |
| OG012 | MAD IFB-088 15.0mg | healthy volunteers received IFB-088 15.0mg daily, in the morning, during 14 days. |
| OG013 | MAD Placebo 15.0mg | healthy volunteers received placebo 15.0mg daily, in the morning, during 14 days. |
| OG014 | MAD IFB-088 30.0mg | healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days. |
| OG015 | MAD Placebo 30.0mg | healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days. |
| OG016 | MAD IFB-088 50.0mg | healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days. |
| OG017 | MAD Placebo 50.0mg | healthy volunteers received placebo 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days. |
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| OG004 | SAD IFB-088 10.0mg | healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval. |
| OG005 | SAD Placebo 10.0mg | healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval. |
| OG006 | SAD IFB-088 20.0mg | healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval. |
| OG007 | SAD Placebo 20.0mg | healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval. |
| OG008 | SAD IFB-088 40.0mg | healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval. |
| OG009 | SAD Placebo 40.0mg | healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval. |
| OG010 | SAD IFB-088 60.0mg | healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval. |
| OG011 | SAD Placebo 60.0mg | healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval. |
| OG012 | MAD IFB-088 15.0mg | healthy volunteers received IFB-088 15.0mg daily, in the morning, during 14 days. |
| OG013 | MAD Placebo 15.0mg | healthy volunteers received placebo 15.0mg daily, in the morning, during 14 days. |
| OG014 | MAD IFB-088 30.0mg | healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days. |
| OG015 | MAD Placebo 30.0mg | healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days. |
| OG016 | MAD IFB-088 50.0mg | healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days. |
| OG017 | MAD Placebo 50.0mg | healthy volunteers received placebo 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days. |
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| OG003 | SAD Placebo 5.0mg | healthy volunteers received placebo 5.0mg once daily, in two doses of 2.5mg, separated by a 12h interval. |
| OG004 | SAD IFB-088 10.0mg | healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval. |
| OG005 | SAD Placebo 10.0mg | healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval. |
| OG006 | SAD IFB-088 20.0mg | healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval. |
| OG007 | SAD Placebo 20.0mg | healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval. |
| OG008 | SAD IFB-088 40.0mg | healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval. |
| OG009 | SAD Placebo 40.0mg | healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval. |
| OG010 | SAD IFB-088 60.0mg | healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval. |
| OG011 | SAD Placebo 60.0mg | healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval. |
| OG012 | MAD IFB-088 15.0mg | healthy volunteers received IFB-088 15.0mg daily, in the morning, during 14 days. |
| OG013 | MAD Placebo 15.0mg | healthy volunteers received placebo 15.0mg daily, in the morning, during 14 days. |
| OG014 | MAD IFB-088 30.0mg | healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days. |
| OG015 | MAD Placebo 30.0mg | healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days. |
| OG016 | MAD IFB-088 50.0mg | healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days. |
| OG017 | MAD Placebo 50.0mg | healthy volunteers received placebo 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days. |
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| OG003 |
| SAD Placebo 5.0mg |
healthy volunteers received placebo 5.0mg once daily, in two doses of 2.5mg, separated by a 12h interval. |
| OG004 | SAD IFB-088 10.0mg | healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval. |
| OG005 | SAD Placebo 10.0mg | healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval. |
| OG006 | SAD IFB-088 20.0mg | healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval. |
| OG007 | SAD Placebo 20.0mg | healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval. |
| OG008 | SAD IFB-088 40.0mg | healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval. |
| OG009 | SAD Placebo 40.0mg | healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval. |
| OG010 | SAD IFB-088 60.0mg | healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval. |
| OG011 | SAD Placebo 60.0mg | healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval. |
| OG012 | MAD IFB-088 15.0mg | healthy volunteers received IFB-088 15.0mg daily, in the morning, during 14 days. |
| OG013 | MAD Placebo 15.0mg | healthy volunteers received placebo 15.0mg daily, in the morning, during 14 days. |
| OG014 | MAD IFB-088 30.0mg | healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days. |
| OG015 | MAD Placebo 30.0mg | healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days. |
| OG016 | MAD IFB-088 50.0mg | healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days. |
| OG017 | MAD Placebo 50.0mg | healthy volunteers received placebo 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days. |
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healthy volunteers received placebo 5.0mg once daily, in two doses of 2.5mg, separated by a 12h interval. |
| OG004 | SAD IFB-088 10.0mg | healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval. |
| OG005 | SAD Placebo 10.0mg | healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval. |
| OG006 | SAD IFB-088 20.0mg | healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval. |
| OG007 | SAD Placebo 20.0mg | healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval. |
| OG008 | SAD IFB-088 40.0mg | healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval. |
| OG009 | SAD Placebo 40.0mg | healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval. |
| OG010 | SAD IFB-088 60.0mg | healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval. |
| OG011 | SAD Placebo 60.0mg | healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval. |
| OG012 | MAD IFB-088 15.0mg | healthy volunteers received IFB-088 15.0mg daily, in the morning, during 14 days. |
| OG013 | MAD Placebo 15.0mg | healthy volunteers received placebo 15.0mg daily, in the morning, during 14 days. |
| OG014 | MAD IFB-088 30.0mg | healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days. |
| OG015 | MAD Placebo 30.0mg | healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days. |
| OG016 | MAD IFB-088 50.0mg | healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days. |
| OG017 | MAD Placebo 50.0mg | healthy volunteers received placebo 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days. |
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