Healthy Volunteers
Conditions
Keywords
First-In-Human
Brief summary
This is the first study of single and multiple doses of IFB-088 in human subjects. The current study is designed to assess in the first part, the safety, tolerability, plasma and urine pharmacokinetics (PK) of single oral doses of IFB-088 in healthy subjects (Single Ascending Doses - SAD) and in a second part safety, tolerability, plasma and urine pharmacokinetics (PK) of multiple oral doses of IFB-088 in healthy subjects (Multiple Ascending Doses - MAD)
Detailed description
Randomized, double blind, placebo controlled study of single ascending doses (SAD) and multiple ascending doses (MAD). The SAD part consists of 6 cohorts of 8 healthy young male subjects, each receiving a single oral dose of IFB-088 or placebo (6 verum and 2 placebo). In each cohort, 2 subjects (1 verum and 1 placebo) will be dosed first. If the safety and tolerability results are acceptable, the 6 remaining subjects will be dosed by 2 successive groups of 3 subjects, with an adequate period between the 2 groups to detect the occurrence of any reaction or adverse events, namely at least 48H for the first cohort and at least 36H for the following cohorts. Indeed, in the first cohort (2.5 mg IFB-088 base), dosing will be in the morning only. From the second cohort, the planned daily dose will be divided into 2 doses separated by an interval of 12 hours (1 dose in the morning fasting and 1 dose in the evening 2 hours before dinner). The MAD part consists of 3 cohorts of 8 healthy young male subjects, each receiving an oral dose divided into two doses of IFB-088 or placebo (6 verum and 2 placebo) for 14 days. In each cohort, the 2 first subjects will be dosed on Day 1 (one on active treatment and one on placebo). The 6 remaining subjects will be dosed by 2 successive groups of maximum 3 subjects with an adequate period between the groups to observe for any reaction and adverse events. This period will be of at least 36H, corresponding to at least 5-fold the half-life of the drug (based on results obtained during the SAD part) when steady state will be achieved. In each MAD cohort, the total daily dose will be divided into 2 doses separated by an interval of 12 hours.
Interventions
DRUGIFB-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
DRUGPlacebo (2.5-60.mg) oral capsule
SAD phase: placebo (microcrystalline cellulosis) will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
DRUGIFB-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.
DRUGPlacebo oral (15.0-50.0mg) capsule
MAD phase: multiple doses of placebo (microcrystalline cellulosis, 15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.
Sponsors
Qualissima
Assistance Publique Hopitaux De Marseille
Stragen France
Eurofins Optimed
InFlectis BioScience
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Capsules used for verum or placebo (Size 5 white opaque HPMC capsule) are identical and equally-weighted
Intervention model description
double-blind, randomized, placebo-controlled, combined single and multiple ascending dose of IFB-088 by successive cohorts study
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male 18 to 40 years of age inclusive, Caucasian. 2. Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests, vital signs and ECG. 3. AST, ALT, alkaline phosphatase and bilirubin \< or = 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). 4. ECG (12 leads) normal (120\<PR\<200ms; QRS\<120ms; QTcF\<450ms) and/or without clinically relevant impairments as judged by investigator. 5. Non-smoker, or user of not more than tobacco- or nicotine-containing products ≤ 5 cigarettes a day. 6. Negative screen for alcohol and drugs of abuse at screening and admission. 7. No history of psychiatric disorders assessed by a clinical psychological evaluation and the Mini International Neuropsychiatric Interview (MINI). 8. Body mass index (BMI) between 19 and 27 kg/m² inclusive. 9. Subject with female partners of child bearing potential must agree to use one of the contraception methods listed in Section 6.6.1 (Contraception requirements). This criterion must be followed from the time of the first dose of study medication until the follow up visit (for female partners) and with an additional period of 90 days (for subjects themselves). 10. Willing and able to understand and sign an approved Informed Consent Form. 11. Able to understand the protocol and to come to the visits. 12. Who is, in the judgement of the investigator likely to be compliant during the study. 13. Subject registered in the VRB file (volontaires se prêtant à des recherches impliquant la personne humaine). 14. Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.
Exclusion criteria
1. 1\. History of asthma, anaphylaxis or anaphylactoid reactions, severe allergic responses. 2. History of relevant atopy or drug hypersensitivity. 3. Known allergy to any component of IFB-088 oral capsule or its placebo (HPMC or cellulose microcrystalline). 4. History of major medical, psychiatric illness or surgery which, in the judgment of the investigator, puts them 'at risk' or is likely to modify their handling of the study drug. 5. Acute or chronic systemic disease or disorder (respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine). 6. Impaired renal function defined by a creatinine clearance \< 90 mL/min calculated using the Cockcroft-Gault equation (according the FDA Guidance for Industry: Pharmacokinetics in patients with Impaired Renal Function, March 2010). 7. History of nephritic colic and/or renal calculi. 8. History of drug abuse and/or regular use of tobacco- or nicotine-containing products \> 5/day within three months of the study. 9. History of alcohol consumption exceeding, (on average 21 drinks/week for men) within 6 months of the first dose of study medication. 10. Drinking excessive amounts of tea, coffee, chocolate and/or beverage containing caffeine (\> 4 cups / day). 11. Vital signs with a clinically significant abnormality at screening. 12. ECG with a clinically significant abnormality at screening. 13. Laboratory test values outside the clinically acceptable 'normal range' for healthy volunteers at screening. 14. Positive HIV, Hepatitis B or Hepatitis C at screening. 15. Positive urine drug test or positive breath alcohol test at screening or at admission to the clinical unit. 16. Any medication (including St John's Wort) within 14 days before administration, or within 5 times the elimination half-life of that drug, whichever is the longest (except paracetamol). 17. Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening. 18. Unable to refrain from consumption of grapefruit or grapefruit juice within 7 days prior to the first dose of study medication. 19. Unwillingness to abstain from sexual intercourse with pregnant or lactating women or to use a condom and spermicide and another form of contraception (e.g., IUD, birth control pills taken by female partner, diaphragm with spermicide) if engaging in sexual intercourse with a woman who could become pregnant until discharge from the study and during 90 additional days. 20. Subjects unlikely to co-operate in the study, and/or poor compliance anticipated by the investigator. 21. Subject being in the exclusion period of a previous trial. 22. Subject having exceeded the earnings for the last 12 months, including the indemnities for the present study. 23. Subject who could not be contacted in case of emergency. 24. Subject refusing to give written informed consent. 25. Subject who has received blood or plasma derivatives in the year preceding the study. 26. Subject who has given blood within the past 3 months or has planned to give blood or sperm within the 90 days following the study. 27. Subject who has forfeited their freedom by administrative or legal award, or who is under guardianship or under limited judicial protection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events Per Group | SAD & MAD phases: Screening visit to End of study visit (7 to 14 days after last dosing) + 30 days | This safety outcome lists the number of subjects experiencing adverse events (AEs), whether not related, possibly or unlikely related to the study treatment. As all the parameters are developped in the pharmacovigilance section, please do refer to that section for further details. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic: Maximum Observed Plasma Concentration (Cmax) | Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17) | 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). |
| Pharmacokinetic: Time to Reach the Maximum Concentration in Plasma (Tmax) | Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17) | 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). |
| Pharmacokinetic: Terminal Half-life (t1/2) | Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17) | 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). |
| Pharmacokinetic: Area Under Plasma Concentration-time Curve From Hour 0 to Last Sample With Measurable Plasma Concentrations (AUClast) | Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17) | 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). |
| Pharmacokinetic: Apparent Volume of Distribution (Vd/F) | Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17) | 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). |
| Pharmacokinetic: Apparent Total Body Clearance (CL/F) | Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17) | 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). |
| Pharmacokinetic: Renal Clearance (CLr) | Starting 1 hour prior to dosing on Day 1 and until 48 hours after last dosing (Day 16) | 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 |
| Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | 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) | 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. |
| Pharmacokinetic: Percent of Drug Recovered in Urine (Ae %Dose) | Starting 1 hour prior to dosing on Day 1 and until 48 hours after last dosing (Day 16) | 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 |
| Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | SAD & MAD phases: Screening; Day 2 (SAD) or Day 17 (MAD); and at End of study visit (7 to 14 days after last dosing) | 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 |
| Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | SAD & MAD phases: Screening; Day 2 (SAD) or Day 17 (MAD); and at End of study visit (7 to 14 days after last dosing) | Weight measured in kg and height measured in cm, were taken and Body Mass Index was calculated using those 2 values |
| Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | From screening visit until end of study visit (7 to 14 days after last dosing) | This safety outcome aims at monitoring cardiovascular functions and identify potential adverse events/reactions (clinical assessment combined with ECGs and vital signs assessments). |
| Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | 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) | 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. |
| Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | 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) | This safety outcome aims at monitoring coagulation parameters such as Activated partial thromboplastin time (APTT), international normalized ratio (INR) |
| Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | 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) | 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 |
| Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | 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) | 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. |
| Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | 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) | 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. |
| Number of Participants With Change in Concomitant Medications | SAD & MAD phases: Continuous (Screening visit to End of study visit (7 to 14 days after last dosing) + 30 days) | modification in Concomitant medication(s) occuring during the study (if applicable) |
Other
| Measure | Time frame | Description |
|---|---|---|
| SAD Exploratory Biomarkers Analysis | SAD phase: Day 1 at predose, 1.5 hours and 24 hours | Blood samples will be collected and stored in a biobank to explore potential biomarkers that remain to be identified |
| MAD Exploratory Biomarkers Analysis | MAD phase: Day 1 and Day 14 at predose, 1.5 hours and 24 hours | Blood samples will be collected and stored in a biobank to explore potential biomarkers that remain to be identified |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 6 |
| 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) | 6 |
| 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) | 6 |
| 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) | 6 |
| 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) | 6 |
| 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) | 6 |
| 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 | 6 |
| 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 | 6 |
| 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 | 6 |
| 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) | 12 |
| 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 | 6 |
| Total | 72 |
Baseline characteristics
| Characteristic | Cohort 1: SAD IFB-088 2.5mg | Cohort 2: SAD IFB-088 5.0mg | Cohort 3: SAD IFB-088 10.0mg | Cohort 4: SAD IFB-088 20.0mg | Cohort 5: SAD IFB-088 40.0mg | Cohort 6: SAD IFB-088 60.0mg | Cohort 7: MAD IFB-088 15.0mg | Cohort 8: MAD IFB-088 30.0mg | Cohort 9: MAD IFB-088 50.0mg | SAD Placebo Group | MAD Placebo Group | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous subject age | 31.0 Year | 25.5 Year | 27.5 Year | 24.7 Year | 24.5 Year | 25.5 Year | 27.0 Year | 31.7 Year | 31.0 Year | 26.5 Year | 31.7 Year | 26.5 Year |
| Race/Ethnicity, Customized Caucasian | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 12 Participants | 6 Participants | 72 Participants |
| Region of Enrollment France | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 12 participants | 6 participants | 72 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 12 Participants | 6 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 12 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 1 / 6 | 1 / 6 | 2 / 6 | 2 / 6 | 2 / 6 | 3 / 6 | 2 / 12 | 4 / 6 | 1 / 6 | 4 / 6 | 2 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 12 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
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.
Time frame: SAD & MAD phases: Screening visit to End of study visit (7 to 14 days after last dosing) + 30 days
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SAD IFB-088 2.5mg | Number of Participants With Treatment Emergent Adverse Events Per Group | 1 Participants |
| SAD Placebo 2.5mg | Number of Participants With Treatment Emergent Adverse Events Per Group | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With Treatment Emergent Adverse Events Per Group | 1 Participants |
| SAD Placebo 5.0mg | Number of Participants With Treatment Emergent Adverse Events Per Group | 1 Participants |
| SAD IFB-088 10.0mg | Number of Participants With Treatment Emergent Adverse Events Per Group | 2 Participants |
| SAD Placebo 10.0mg | Number of Participants With Treatment Emergent Adverse Events Per Group | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With Treatment Emergent Adverse Events Per Group | 2 Participants |
| SAD Placebo 20.0mg | Number of Participants With Treatment Emergent Adverse Events Per Group | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With Treatment Emergent Adverse Events Per Group | 2 Participants |
| SAD Placebo 40.0mg | Number of Participants With Treatment Emergent Adverse Events Per Group | 1 Participants |
| SAD IFB-088 60.0mg | Number of Participants With Treatment Emergent Adverse Events Per Group | 3 Participants |
| SAD Placebo 60.0mg | Number of Participants With Treatment Emergent Adverse Events Per Group | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With Treatment Emergent Adverse Events Per Group | 4 Participants |
| MAD Placebo 15.0mg | Number of Participants With Treatment Emergent Adverse Events Per Group | 1 Participants |
| MAD IFB-088 30.0mg | Number of Participants With Treatment Emergent Adverse Events Per Group | 1 Participants |
| MAD Placebo 30.0mg | Number of Participants With Treatment Emergent Adverse Events Per Group | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With Treatment Emergent Adverse Events Per Group | 4 Participants |
| MAD Placebo 50.0mg | Number of Participants With Treatment Emergent Adverse Events Per Group | 1 Participants |
Secondary
Number of Participants With Change in Concomitant Medications
modification in Concomitant medication(s) occuring during the study (if applicable)
Time frame: SAD & MAD phases: Continuous (Screening visit to End of study visit (7 to 14 days after last dosing) + 30 days)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SAD IFB-088 2.5mg | Number of Participants With Change in Concomitant Medications | add-on: naproxen 550mg bid | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With Change in Concomitant Medications | add-on: fexofenadine 180mg 1/day | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With Change in Concomitant Medications | add-on: desloratadine 5 mg as needed | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With Change in Concomitant Medications | add-on: acetaminophen 1000mg 1/day | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With Change in Concomitant Medications | number of participants without change | 6 Participants |
| SAD Placebo 2.5mg | Number of Participants With Change in Concomitant Medications | add-on: desloratadine 5 mg as needed | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With Change in Concomitant Medications | add-on: acetaminophen 1000mg 1/day | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With Change in Concomitant Medications | add-on: fexofenadine 180mg 1/day | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With Change in Concomitant Medications | number of participants without change | 2 Participants |
| SAD Placebo 2.5mg | Number of Participants With Change in Concomitant Medications | add-on: naproxen 550mg bid | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With Change in Concomitant Medications | number of participants without change | 6 Participants |
| SAD IFB-088 5.0mg | Number of Participants With Change in Concomitant Medications | add-on: naproxen 550mg bid | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With Change in Concomitant Medications | add-on: acetaminophen 1000mg 1/day | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With Change in Concomitant Medications | add-on: desloratadine 5 mg as needed | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With Change in Concomitant Medications | add-on: fexofenadine 180mg 1/day | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With Change in Concomitant Medications | add-on: desloratadine 5 mg as needed | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With Change in Concomitant Medications | add-on: fexofenadine 180mg 1/day | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With Change in Concomitant Medications | number of participants without change | 2 Participants |
| SAD Placebo 5.0mg | Number of Participants With Change in Concomitant Medications | add-on: acetaminophen 1000mg 1/day | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With Change in Concomitant Medications | add-on: naproxen 550mg bid | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With Change in Concomitant Medications | add-on: desloratadine 5 mg as needed | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With Change in Concomitant Medications | add-on: acetaminophen 1000mg 1/day | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With Change in Concomitant Medications | number of participants without change | 6 Participants |
| SAD IFB-088 10.0mg | Number of Participants With Change in Concomitant Medications | add-on: naproxen 550mg bid | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With Change in Concomitant Medications | add-on: fexofenadine 180mg 1/day | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With Change in Concomitant Medications | add-on: fexofenadine 180mg 1/day | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With Change in Concomitant Medications | add-on: naproxen 550mg bid | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With Change in Concomitant Medications | add-on: desloratadine 5 mg as needed | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With Change in Concomitant Medications | add-on: acetaminophen 1000mg 1/day | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With Change in Concomitant Medications | number of participants without change | 2 Participants |
| SAD IFB-088 20.0mg | Number of Participants With Change in Concomitant Medications | add-on: naproxen 550mg bid | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With Change in Concomitant Medications | add-on: fexofenadine 180mg 1/day | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With Change in Concomitant Medications | add-on: desloratadine 5 mg as needed | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With Change in Concomitant Medications | number of participants without change | 5 Participants |
| SAD IFB-088 20.0mg | Number of Participants With Change in Concomitant Medications | add-on: acetaminophen 1000mg 1/day | 1 Participants |
| SAD Placebo 20.0mg | Number of Participants With Change in Concomitant Medications | number of participants without change | 2 Participants |
| SAD Placebo 20.0mg | Number of Participants With Change in Concomitant Medications | add-on: naproxen 550mg bid | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With Change in Concomitant Medications | add-on: fexofenadine 180mg 1/day | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With Change in Concomitant Medications | add-on: desloratadine 5 mg as needed | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With Change in Concomitant Medications | add-on: acetaminophen 1000mg 1/day | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With Change in Concomitant Medications | add-on: naproxen 550mg bid | 1 Participants |
| SAD IFB-088 40.0mg | Number of Participants With Change in Concomitant Medications | number of participants without change | 5 Participants |
| SAD IFB-088 40.0mg | Number of Participants With Change in Concomitant Medications | add-on: acetaminophen 1000mg 1/day | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With Change in Concomitant Medications | add-on: desloratadine 5 mg as needed | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With Change in Concomitant Medications | add-on: fexofenadine 180mg 1/day | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With Change in Concomitant Medications | add-on: acetaminophen 1000mg 1/day | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With Change in Concomitant Medications | number of participants without change | 2 Participants |
| SAD Placebo 40.0mg | Number of Participants With Change in Concomitant Medications | add-on: naproxen 550mg bid | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With Change in Concomitant Medications | add-on: fexofenadine 180mg 1/day | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With Change in Concomitant Medications | add-on: desloratadine 5 mg as needed | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With Change in Concomitant Medications | add-on: naproxen 550mg bid | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With Change in Concomitant Medications | add-on: fexofenadine 180mg 1/day | 1 Participants |
| SAD IFB-088 60.0mg | Number of Participants With Change in Concomitant Medications | number of participants without change | 4 Participants |
| SAD IFB-088 60.0mg | Number of Participants With Change in Concomitant Medications | add-on: acetaminophen 1000mg 1/day | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With Change in Concomitant Medications | add-on: desloratadine 5 mg as needed | 1 Participants |
| SAD Placebo 60.0mg | Number of Participants With Change in Concomitant Medications | add-on: fexofenadine 180mg 1/day | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With Change in Concomitant Medications | add-on: naproxen 550mg bid | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With Change in Concomitant Medications | add-on: desloratadine 5 mg as needed | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With Change in Concomitant Medications | add-on: acetaminophen 1000mg 1/day | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With Change in Concomitant Medications | number of participants without change | 2 Participants |
| MAD IFB-088 15.0mg | Number of Participants With Change in Concomitant Medications | add-on: naproxen 550mg bid | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With Change in Concomitant Medications | add-on: acetaminophen 1000mg 1/day | 1 Participants |
| MAD IFB-088 15.0mg | Number of Participants With Change in Concomitant Medications | number of participants without change | 5 Participants |
| MAD IFB-088 15.0mg | Number of Participants With Change in Concomitant Medications | add-on: fexofenadine 180mg 1/day | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With Change in Concomitant Medications | add-on: desloratadine 5 mg as needed | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With Change in Concomitant Medications | add-on: fexofenadine 180mg 1/day | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With Change in Concomitant Medications | add-on: desloratadine 5 mg as needed | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With Change in Concomitant Medications | add-on: acetaminophen 1000mg 1/day | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With Change in Concomitant Medications | add-on: naproxen 550mg bid | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With Change in Concomitant Medications | number of participants without change | 2 Participants |
| MAD IFB-088 30.0mg | Number of Participants With Change in Concomitant Medications | add-on: naproxen 550mg bid | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With Change in Concomitant Medications | number of participants without change | 6 Participants |
| MAD IFB-088 30.0mg | Number of Participants With Change in Concomitant Medications | add-on: desloratadine 5 mg as needed | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With Change in Concomitant Medications | add-on: acetaminophen 1000mg 1/day | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With Change in Concomitant Medications | add-on: fexofenadine 180mg 1/day | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With Change in Concomitant Medications | add-on: naproxen 550mg bid | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With Change in Concomitant Medications | add-on: fexofenadine 180mg 1/day | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With Change in Concomitant Medications | number of participants without change | 2 Participants |
| MAD Placebo 30.0mg | Number of Participants With Change in Concomitant Medications | add-on: acetaminophen 1000mg 1/day | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With Change in Concomitant Medications | add-on: desloratadine 5 mg as needed | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With Change in Concomitant Medications | add-on: acetaminophen 1000mg 1/day | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With Change in Concomitant Medications | add-on: desloratadine 5 mg as needed | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With Change in Concomitant Medications | number of participants without change | 6 Participants |
| MAD IFB-088 50.0mg | Number of Participants With Change in Concomitant Medications | add-on: fexofenadine 180mg 1/day | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With Change in Concomitant Medications | add-on: naproxen 550mg bid | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With Change in Concomitant Medications | add-on: desloratadine 5 mg as needed | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With Change in Concomitant Medications | add-on: naproxen 550mg bid | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With Change in Concomitant Medications | add-on: acetaminophen 1000mg 1/day | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With Change in Concomitant Medications | add-on: fexofenadine 180mg 1/day | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With Change in Concomitant Medications | number of participants without change | 2 Participants |
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
Time frame: SAD & MAD phases: Screening; Day 2 (SAD) or Day 17 (MAD); and at End of study visit (7 to 14 days after last dosing)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SAD IFB-088 2.5mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | liver and biliary tract | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | ENT system | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | visual system | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | general condition | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | cardiavascular system | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | number of participants with no clinically significant changes | 6 Participants |
| SAD IFB-088 2.5mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | respiratory system | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | muco-cutaneous system | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | digestive system | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | lymphatic system | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | digestive system | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | muco-cutaneous system | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | ENT system | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | liver and biliary tract | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | number of participants with no clinically significant changes | 2 Participants |
| SAD Placebo 2.5mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | visual system | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | lymphatic system | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | general condition | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | respiratory system | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | cardiavascular system | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | cardiavascular system | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | number of participants with no clinically significant changes | 6 Participants |
| SAD IFB-088 5.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | visual system | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | respiratory system | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | digestive system | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | ENT system | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | muco-cutaneous system | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | lymphatic system | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | liver and biliary tract | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | general condition | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | lymphatic system | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | cardiavascular system | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | respiratory system | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | visual system | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | liver and biliary tract | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | general condition | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | muco-cutaneous system | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | number of participants with no clinically significant changes | 2 Participants |
| SAD Placebo 5.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | digestive system | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | ENT system | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | digestive system | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | cardiavascular system | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | general condition | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | liver and biliary tract | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | lymphatic system | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | muco-cutaneous system | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | ENT system | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | respiratory system | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | visual system | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | number of participants with no clinically significant changes | 6 Participants |
| SAD Placebo 10.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | liver and biliary tract | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | ENT system | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | respiratory system | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | visual system | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | lymphatic system | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | muco-cutaneous system | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | general condition | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | digestive system | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | number of participants with no clinically significant changes | 2 Participants |
| SAD Placebo 10.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | cardiavascular system | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | muco-cutaneous system | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | general condition | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | number of participants with no clinically significant changes | 6 Participants |
| SAD IFB-088 20.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | liver and biliary tract | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | cardiavascular system | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | visual system | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | respiratory system | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | lymphatic system | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | ENT system | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | digestive system | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | muco-cutaneous system | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | general condition | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | ENT system | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | liver and biliary tract | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | respiratory system | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | number of participants with no clinically significant changes | 2 Participants |
| SAD Placebo 20.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | cardiavascular system | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | digestive system | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | lymphatic system | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | visual system | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | lymphatic system | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | liver and biliary tract | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | respiratory system | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | ENT system | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | number of participants with no clinically significant changes | 5 Participants |
| SAD IFB-088 40.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | muco-cutaneous system | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | general condition | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | digestive system | 1 Participants |
| SAD IFB-088 40.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | cardiavascular system | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | visual system | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | cardiavascular system | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | liver and biliary tract | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | lymphatic system | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | digestive system | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | muco-cutaneous system | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | ENT system | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | respiratory system | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | visual system | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | number of participants with no clinically significant changes | 2 Participants |
| SAD Placebo 40.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | general condition | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | muco-cutaneous system | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | number of participants with no clinically significant changes | 6 Participants |
| SAD IFB-088 60.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | digestive system | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | ENT system | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | lymphatic system | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | liver and biliary tract | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | respiratory system | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | general condition | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | cardiavascular system | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | visual system | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | respiratory system | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | general condition | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | visual system | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | ENT system | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | muco-cutaneous system | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | lymphatic system | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | digestive system | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | number of participants with no clinically significant changes | 2 Participants |
| SAD Placebo 60.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | cardiavascular system | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | liver and biliary tract | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | liver and biliary tract | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | digestive system | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | general condition | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | cardiavascular system | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | respiratory system | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | ENT system | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | visual system | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | number of participants with no clinically significant changes | 6 Participants |
| MAD IFB-088 15.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | lymphatic system | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | muco-cutaneous system | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | visual system | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | ENT system | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | number of participants with no clinically significant changes | 2 Participants |
| MAD Placebo 15.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | lymphatic system | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | muco-cutaneous system | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | cardiavascular system | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | digestive system | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | respiratory system | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | liver and biliary tract | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | general condition | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | respiratory system | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | liver and biliary tract | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | visual system | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | number of participants with no clinically significant changes | 6 Participants |
| MAD IFB-088 30.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | digestive system | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | muco-cutaneous system | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | cardiavascular system | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | general condition | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | lymphatic system | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | ENT system | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | liver and biliary tract | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | muco-cutaneous system | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | lymphatic system | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | ENT system | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | cardiavascular system | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | number of participants with no clinically significant changes | 2 Participants |
| MAD Placebo 30.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | digestive system | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | respiratory system | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | visual system | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | general condition | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | visual system | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | number of participants with no clinically significant changes | 6 Participants |
| MAD IFB-088 50.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | respiratory system | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | digestive system | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | general condition | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | cardiavascular system | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | lymphatic system | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | ENT system | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | muco-cutaneous system | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | liver and biliary tract | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | lymphatic system | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | visual system | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | cardiavascular system | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | liver and biliary tract | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | respiratory system | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | ENT system | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | number of participants with no clinically significant changes | 2 Participants |
| MAD Placebo 50.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | muco-cutaneous system | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | digestive system | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With Clinically Significant Change in Physical Evaluation During the Study | general condition | 0 Participants |
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
Time frame: SAD & MAD phases: Screening; Day 2 (SAD) or Day 17 (MAD); and at End of study visit (7 to 14 days after last dosing)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SAD IFB-088 2.5mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | number of participants without clinically significant changes | 6 Participants |
| SAD IFB-088 2.5mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of subjects with clinically significant change in weight | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of participants with clinically significant change in BMI | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of subjects with clinically significant change in weight | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of participants with clinically significant change in BMI | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | number of participants without clinically significant changes | 2 Participants |
| SAD IFB-088 5.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of participants with clinically significant change in BMI | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of subjects with clinically significant change in weight | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | number of participants without clinically significant changes | 6 Participants |
| SAD Placebo 5.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | number of participants without clinically significant changes | 2 Participants |
| SAD Placebo 5.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of subjects with clinically significant change in weight | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of participants with clinically significant change in BMI | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of participants with clinically significant change in BMI | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of subjects with clinically significant change in weight | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | number of participants without clinically significant changes | 6 Participants |
| SAD Placebo 10.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | number of participants without clinically significant changes | 2 Participants |
| SAD Placebo 10.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of subjects with clinically significant change in weight | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of participants with clinically significant change in BMI | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | number of participants without clinically significant changes | 6 Participants |
| SAD IFB-088 20.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of subjects with clinically significant change in weight | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of participants with clinically significant change in BMI | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of subjects with clinically significant change in weight | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of participants with clinically significant change in BMI | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | number of participants without clinically significant changes | 2 Participants |
| SAD IFB-088 40.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of participants with clinically significant change in BMI | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | number of participants without clinically significant changes | 6 Participants |
| SAD IFB-088 40.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of subjects with clinically significant change in weight | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of participants with clinically significant change in BMI | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of subjects with clinically significant change in weight | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | number of participants without clinically significant changes | 2 Participants |
| SAD IFB-088 60.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of participants with clinically significant change in BMI | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | number of participants without clinically significant changes | 6 Participants |
| SAD IFB-088 60.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of subjects with clinically significant change in weight | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of participants with clinically significant change in BMI | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | number of participants without clinically significant changes | 2 Participants |
| SAD Placebo 60.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of subjects with clinically significant change in weight | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of subjects with clinically significant change in weight | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of participants with clinically significant change in BMI | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | number of participants without clinically significant changes | 6 Participants |
| MAD Placebo 15.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of subjects with clinically significant change in weight | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | number of participants without clinically significant changes | 2 Participants |
| MAD Placebo 15.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of participants with clinically significant change in BMI | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of participants with clinically significant change in BMI | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of subjects with clinically significant change in weight | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | number of participants without clinically significant changes | 6 Participants |
| MAD Placebo 30.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of subjects with clinically significant change in weight | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of participants with clinically significant change in BMI | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | number of participants without clinically significant changes | 2 Participants |
| MAD IFB-088 50.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of participants with clinically significant change in BMI | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | number of participants without clinically significant changes | 6 Participants |
| MAD IFB-088 50.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of subjects with clinically significant change in weight | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of participants with clinically significant change in BMI | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | Number of subjects with clinically significant change in weight | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With Clinically Significant Change in Physiological Parameters During the Study | number of participants without clinically significant changes | 2 Participants |
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.
Time frame: SAD phase: Screening; Day -1; Day 1 (predose, 12, 24, 32 hours); end of study visit (7 to 14 days after last dosing) MAD phase: Screening; Day -1; predose at Day 1, Day 3, Day 6, Day 10, Day 13; Day 17; end of study visit (7 to 14 days after last dosing)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SAD IFB-088 2.5mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of creatinuria | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of proteinuria | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | Nr of participants with clinically significant change of parameters present on dispstick (see above) | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants without clinically significant changes of urinary parameters | 6 Participants |
| SAD IFB-088 2.5mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of beta2 microglobulin | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of proteinuria | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | Nr of participants with clinically significant change of parameters present on dispstick (see above) | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of beta2 microglobulin | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants without clinically significant changes of urinary parameters | 2 Participants |
| SAD Placebo 2.5mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of creatinuria | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of proteinuria | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | Nr of participants with clinically significant change of parameters present on dispstick (see above) | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of creatinuria | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of beta2 microglobulin | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants without clinically significant changes of urinary parameters | 6 Participants |
| SAD Placebo 5.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of creatinuria | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | Nr of participants with clinically significant change of parameters present on dispstick (see above) | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants without clinically significant changes of urinary parameters | 2 Participants |
| SAD Placebo 5.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of beta2 microglobulin | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of proteinuria | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | Nr of participants with clinically significant change of parameters present on dispstick (see above) | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of creatinuria | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of beta2 microglobulin | 00 Participants |
| SAD IFB-088 10.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants without clinically significant changes of urinary parameters | 6 Participants |
| SAD IFB-088 10.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of proteinuria | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants without clinically significant changes of urinary parameters | 2 Participants |
| SAD Placebo 10.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of beta2 microglobulin | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of creatinuria | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | Nr of participants with clinically significant change of parameters present on dispstick (see above) | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of proteinuria | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of creatinuria | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | Nr of participants with clinically significant change of parameters present on dispstick (see above) | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of proteinuria | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants without clinically significant changes of urinary parameters | 6 Participants |
| SAD IFB-088 20.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of beta2 microglobulin | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of creatinuria | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | Nr of participants with clinically significant change of parameters present on dispstick (see above) | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of proteinuria | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of beta2 microglobulin | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants without clinically significant changes of urinary parameters | 2 Participants |
| SAD IFB-088 40.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | Nr of participants with clinically significant change of parameters present on dispstick (see above) | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of beta2 microglobulin | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of creatinuria | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants without clinically significant changes of urinary parameters | 6 Participants |
| SAD IFB-088 40.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of proteinuria | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of proteinuria | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | Nr of participants with clinically significant change of parameters present on dispstick (see above) | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of beta2 microglobulin | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of creatinuria | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants without clinically significant changes of urinary parameters | 2 Participants |
| SAD IFB-088 60.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of creatinuria | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of beta2 microglobulin | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of proteinuria | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants without clinically significant changes of urinary parameters | 6 Participants |
| SAD IFB-088 60.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | Nr of participants with clinically significant change of parameters present on dispstick (see above) | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants without clinically significant changes of urinary parameters | 2 Participants |
| SAD Placebo 60.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | Nr of participants with clinically significant change of parameters present on dispstick (see above) | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of beta2 microglobulin | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of creatinuria | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of proteinuria | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | Nr of participants with clinically significant change of parameters present on dispstick (see above) | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants without clinically significant changes of urinary parameters | 6 Participants |
| MAD IFB-088 15.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of beta2 microglobulin | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of creatinuria | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of proteinuria | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants without clinically significant changes of urinary parameters | 2 Participants |
| MAD Placebo 15.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | Nr of participants with clinically significant change of parameters present on dispstick (see above) | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of creatinuria | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of beta2 microglobulin | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of proteinuria | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of proteinuria | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of beta2 microglobulin | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of creatinuria | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | Nr of participants with clinically significant change of parameters present on dispstick (see above) | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants without clinically significant changes of urinary parameters | 6 Participants |
| MAD Placebo 30.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | Nr of participants with clinically significant change of parameters present on dispstick (see above) | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of creatinuria | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of beta2 microglobulin | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of proteinuria | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants without clinically significant changes of urinary parameters | 2 Participants |
| MAD IFB-088 50.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of beta2 microglobulin | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of proteinuria | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | Nr of participants with clinically significant change of parameters present on dispstick (see above) | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of creatinuria | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants without clinically significant changes of urinary parameters | 6 Participants |
| MAD Placebo 50.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | Nr of participants with clinically significant change of parameters present on dispstick (see above) | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants without clinically significant changes of urinary parameters | 2 Participants |
| MAD Placebo 50.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of beta2 microglobulin | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of proteinuria | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study | number of participants with clinically significant changes of creatinuria | 0 Participants |
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.
Time frame: SAD Phase: Screening; Day 1 (predose, 1.5, 12, 32 hours) MAD Phase: Screening; Day 1 (predose, 1.5, 12 hours); Day 14 (predose, 1.5, 12 hours)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SAD IFB-088 2.5mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants with clinically significant changes of vigilance or mood during the study | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants without clinically significant changes of vigilance or mood during the study | 6 Participants |
| SAD Placebo 2.5mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants with clinically significant changes of vigilance or mood during the study | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants without clinically significant changes of vigilance or mood during the study | 2 Participants |
| SAD IFB-088 5.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants with clinically significant changes of vigilance or mood during the study | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants without clinically significant changes of vigilance or mood during the study | 6 Participants |
| SAD Placebo 5.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants with clinically significant changes of vigilance or mood during the study | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants without clinically significant changes of vigilance or mood during the study | 2 Participants |
| SAD IFB-088 10.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants without clinically significant changes of vigilance or mood during the study | 6 Participants |
| SAD IFB-088 10.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants with clinically significant changes of vigilance or mood during the study | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants without clinically significant changes of vigilance or mood during the study | 2 Participants |
| SAD Placebo 10.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants with clinically significant changes of vigilance or mood during the study | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants with clinically significant changes of vigilance or mood during the study | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants without clinically significant changes of vigilance or mood during the study | 6 Participants |
| SAD Placebo 20.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants with clinically significant changes of vigilance or mood during the study | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants without clinically significant changes of vigilance or mood during the study | 2 Participants |
| SAD IFB-088 40.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants without clinically significant changes of vigilance or mood during the study | 6 Participants |
| SAD IFB-088 40.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants with clinically significant changes of vigilance or mood during the study | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants without clinically significant changes of vigilance or mood during the study | 2 Participants |
| SAD Placebo 40.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants with clinically significant changes of vigilance or mood during the study | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants without clinically significant changes of vigilance or mood during the study | 6 Participants |
| SAD IFB-088 60.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants with clinically significant changes of vigilance or mood during the study | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants without clinically significant changes of vigilance or mood during the study | 2 Participants |
| SAD Placebo 60.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants with clinically significant changes of vigilance or mood during the study | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants with clinically significant changes of vigilance or mood during the study | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants without clinically significant changes of vigilance or mood during the study | 6 Participants |
| MAD Placebo 15.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants with clinically significant changes of vigilance or mood during the study | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants without clinically significant changes of vigilance or mood during the study | 2 Participants |
| MAD IFB-088 30.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants with clinically significant changes of vigilance or mood during the study | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants without clinically significant changes of vigilance or mood during the study | 6 Participants |
| MAD Placebo 30.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants with clinically significant changes of vigilance or mood during the study | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants without clinically significant changes of vigilance or mood during the study | 2 Participants |
| MAD IFB-088 50.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants with clinically significant changes of vigilance or mood during the study | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants without clinically significant changes of vigilance or mood during the study | 6 Participants |
| MAD Placebo 50.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants with clinically significant changes of vigilance or mood during the study | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study | number of participants without clinically significant changes of vigilance or mood during the study | 2 Participants |
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
Time frame: SAD phase: Screening; Day -1; Day 2 (24 hours); end of study visit (7 to 14 days after last dosing) MAD phase: Screening; Day -1; predose at Day 3, Day 6, Day 10, Day 13; Day 17; end of study visit (7 to 14 days after last dosing)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in triglycerides | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in glycaemia | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in lactate dehydrogenase (LDH) | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total protein | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants without clinically significant changes in biochem. param. throughout the study | 6 Participants |
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in aminotransferases (ASAT, ALAT, GGT) | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in cholesterol (total, HDL, LDL) | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants with clinically significant changes in creatinine and creatinine phosphokinase | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total bilirubin | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in alkaline phosphatases | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in albumin | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in urea and uric acid | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in ion (Na, K, Cl, Ca, HCO3) | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in triglycerides | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in urea and uric acid | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in alkaline phosphatases | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in ion (Na, K, Cl, Ca, HCO3) | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in albumin | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total bilirubin | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants with clinically significant changes in creatinine and creatinine phosphokinase | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants without clinically significant changes in biochem. param. throughout the study | 2 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in aminotransferases (ASAT, ALAT, GGT) | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in lactate dehydrogenase (LDH) | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in glycaemia | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total protein | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in cholesterol (total, HDL, LDL) | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in urea and uric acid | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in triglycerides | 1 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in alkaline phosphatases | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in albumin | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants without clinically significant changes in biochem. param. throughout the study | 5 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in aminotransferases (ASAT, ALAT, GGT) | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total bilirubin | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in ion (Na, K, Cl, Ca, HCO3) | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total protein | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in lactate dehydrogenase (LDH) | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in cholesterol (total, HDL, LDL) | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in glycaemia | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants with clinically significant changes in creatinine and creatinine phosphokinase | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in cholesterol (total, HDL, LDL) | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in albumin | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in urea and uric acid | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in glycaemia | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants with clinically significant changes in creatinine and creatinine phosphokinase | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total protein | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in ion (Na, K, Cl, Ca, HCO3) | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in aminotransferases (ASAT, ALAT, GGT) | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants without clinically significant changes in biochem. param. throughout the study | 1 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in alkaline phosphatases | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in lactate dehydrogenase (LDH) | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total bilirubin | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in triglycerides | 1 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in triglycerides | 1 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total protein | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants without clinically significant changes in biochem. param. throughout the study | 5 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in aminotransferases (ASAT, ALAT, GGT) | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in lactate dehydrogenase (LDH) | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in cholesterol (total, HDL, LDL) | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants with clinically significant changes in creatinine and creatinine phosphokinase | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in ion (Na, K, Cl, Ca, HCO3) | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in urea and uric acid | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in glycaemia | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total bilirubin | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in albumin | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in alkaline phosphatases | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in aminotransferases (ASAT, ALAT, GGT) | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total bilirubin | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants with clinically significant changes in creatinine and creatinine phosphokinase | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in ion (Na, K, Cl, Ca, HCO3) | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in cholesterol (total, HDL, LDL) | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in lactate dehydrogenase (LDH) | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in triglycerides | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in urea and uric acid | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in alkaline phosphatases | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total protein | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in glycaemia | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in albumin | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants without clinically significant changes in biochem. param. throughout the study | 2 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants without clinically significant changes in biochem. param. throughout the study | 6 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in triglycerides | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in aminotransferases (ASAT, ALAT, GGT) | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in alkaline phosphatases | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total bilirubin | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in ion (Na, K, Cl, Ca, HCO3) | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in cholesterol (total, HDL, LDL) | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in glycaemia | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in urea and uric acid | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants with clinically significant changes in creatinine and creatinine phosphokinase | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in lactate dehydrogenase (LDH) | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total protein | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in albumin | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in ion (Na, K, Cl, Ca, HCO3) | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants with clinically significant changes in creatinine and creatinine phosphokinase | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in urea and uric acid | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in cholesterol (total, HDL, LDL) | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in glycaemia | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in lactate dehydrogenase (LDH) | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in albumin | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in aminotransferases (ASAT, ALAT, GGT) | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total bilirubin | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in alkaline phosphatases | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants without clinically significant changes in biochem. param. throughout the study | 1 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total protein | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in triglycerides | 1 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in triglycerides | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total protein | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in alkaline phosphatases | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in albumin | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants without clinically significant changes in biochem. param. throughout the study | 6 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in ion (Na, K, Cl, Ca, HCO3) | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in glycaemia | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in cholesterol (total, HDL, LDL) | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants with clinically significant changes in creatinine and creatinine phosphokinase | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in urea and uric acid | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total bilirubin | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in aminotransferases (ASAT, ALAT, GGT) | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in lactate dehydrogenase (LDH) | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in alkaline phosphatases | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in ion (Na, K, Cl, Ca, HCO3) | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in aminotransferases (ASAT, ALAT, GGT) | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in cholesterol (total, HDL, LDL) | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in triglycerides | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in glycaemia | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total bilirubin | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total protein | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in albumin | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in urea and uric acid | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants with clinically significant changes in creatinine and creatinine phosphokinase | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in lactate dehydrogenase (LDH) | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants without clinically significant changes in biochem. param. throughout the study | 2 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in aminotransferases (ASAT, ALAT, GGT) | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in lactate dehydrogenase (LDH) | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants with clinically significant changes in creatinine and creatinine phosphokinase | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in cholesterol (total, HDL, LDL) | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in glycaemia | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total bilirubin | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in alkaline phosphatases | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in urea and uric acid | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants without clinically significant changes in biochem. param. throughout the study | 4 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total protein | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in triglycerides | 2 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in albumin | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in ion (Na, K, Cl, Ca, HCO3) | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in albumin | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in aminotransferases (ASAT, ALAT, GGT) | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants without clinically significant changes in biochem. param. throughout the study | 2 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in lactate dehydrogenase (LDH) | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total protein | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in glycaemia | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in ion (Na, K, Cl, Ca, HCO3) | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in triglycerides | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in urea and uric acid | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total bilirubin | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in cholesterol (total, HDL, LDL) | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in alkaline phosphatases | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants with clinically significant changes in creatinine and creatinine phosphokinase | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants without clinically significant changes in biochem. param. throughout the study | 6 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants with clinically significant changes in creatinine and creatinine phosphokinase | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total protein | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in cholesterol (total, HDL, LDL) | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in alkaline phosphatases | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total bilirubin | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in ion (Na, K, Cl, Ca, HCO3) | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in albumin | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in lactate dehydrogenase (LDH) | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in glycaemia | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in urea and uric acid | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in aminotransferases (ASAT, ALAT, GGT) | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in triglycerides | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants without clinically significant changes in biochem. param. throughout the study | 2 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in triglycerides | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in alkaline phosphatases | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in ion (Na, K, Cl, Ca, HCO3) | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total bilirubin | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in cholesterol (total, HDL, LDL) | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in urea and uric acid | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total protein | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants with clinically significant changes in creatinine and creatinine phosphokinase | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in aminotransferases (ASAT, ALAT, GGT) | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in glycaemia | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in lactate dehydrogenase (LDH) | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in albumin | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in ion (Na, K, Cl, Ca, HCO3) | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total protein | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total bilirubin | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in glycaemia | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in albumin | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in triglycerides | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants without clinically significant changes in biochem. param. throughout the study | 6 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in urea and uric acid | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in cholesterol (total, HDL, LDL) | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants with clinically significant changes in creatinine and creatinine phosphokinase | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in aminotransferases (ASAT, ALAT, GGT) | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in lactate dehydrogenase (LDH) | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in alkaline phosphatases | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants with clinically significant changes in creatinine and creatinine phosphokinase | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in aminotransferases (ASAT, ALAT, GGT) | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in urea and uric acid | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in triglycerides | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in lactate dehydrogenase (LDH) | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in albumin | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in ion (Na, K, Cl, Ca, HCO3) | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in glycaemia | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total protein | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total bilirubin | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants without clinically significant changes in biochem. param. throughout the study | 2 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in cholesterol (total, HDL, LDL) | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in alkaline phosphatases | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants without clinically significant changes in biochem. param. throughout the study | 6 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in albumin | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total bilirubin | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in lactate dehydrogenase (LDH) | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in ion (Na, K, Cl, Ca, HCO3) | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in cholesterol (total, HDL, LDL) | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in alkaline phosphatases | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in glycaemia | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants with clinically significant changes in creatinine and creatinine phosphokinase | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in aminotransferases (ASAT, ALAT, GGT) | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in urea and uric acid | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total protein | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in triglycerides | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in glycaemia | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in triglycerides | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in albumin | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total bilirubin | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants with clinically significant changes in creatinine and creatinine phosphokinase | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | Nr of participants without clinically significant changes in biochem. param. throughout the study | 2 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in cholesterol (total, HDL, LDL) | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in lactate dehydrogenase (LDH) | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in alkaline phosphatases | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in ion (Na, K, Cl, Ca, HCO3) | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in urea and uric acid | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in aminotransferases (ASAT, ALAT, GGT) | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study | number of participants with clinically significant changes in total protein | 0 Participants |
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).
Time frame: From screening visit until end of study visit (7 to 14 days after last dosing)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with clinically significant change in electrocardiogram parameters (ECG) | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with no clinically significant changes in ECG | 6 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with clinically significant change in electrocardiogram parameters (ECG) | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with no clinically significant changes in ECG | 2 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with clinically significant change in electrocardiogram parameters (ECG) | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with no clinically significant changes in ECG | 6 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with clinically significant change in electrocardiogram parameters (ECG) | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with no clinically significant changes in ECG | 2 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with no clinically significant changes in ECG | 6 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with clinically significant change in electrocardiogram parameters (ECG) | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with no clinically significant changes in ECG | 2 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with clinically significant change in electrocardiogram parameters (ECG) | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with clinically significant change in electrocardiogram parameters (ECG) | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with no clinically significant changes in ECG | 6 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with clinically significant change in electrocardiogram parameters (ECG) | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with no clinically significant changes in ECG | 2 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with no clinically significant changes in ECG | 6 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with clinically significant change in electrocardiogram parameters (ECG) | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with no clinically significant changes in ECG | 2 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with clinically significant change in electrocardiogram parameters (ECG) | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with no clinically significant changes in ECG | 6 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with clinically significant change in electrocardiogram parameters (ECG) | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with no clinically significant changes in ECG | 2 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with clinically significant change in electrocardiogram parameters (ECG) | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with clinically significant change in electrocardiogram parameters (ECG) | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with no clinically significant changes in ECG | 6 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with clinically significant change in electrocardiogram parameters (ECG) | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with no clinically significant changes in ECG | 2 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with clinically significant change in electrocardiogram parameters (ECG) | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with no clinically significant changes in ECG | 6 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with clinically significant change in electrocardiogram parameters (ECG) | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with no clinically significant changes in ECG | 2 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with clinically significant change in electrocardiogram parameters (ECG) | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with no clinically significant changes in ECG | 6 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with clinically significant change in electrocardiogram parameters (ECG) | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study | Number of participants with no clinically significant changes in ECG | 2 Participants |
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)
Time frame: SAD phase: Screening; Day -1; Day 2 (24 hours); end of study visit (7 to 14 days after last dosing) MAD phase: Screening; Day -1; predose at Day 3, Day 6, Day 10, Day ; Day 17; end of study visit (7 to 14 days after last dosing)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in APTT during the study | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in INR during the study | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants without clinically significant changes in coagulation throughout the study | 6 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants without clinically significant changes in coagulation throughout the study | 2 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in INR during the study | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in APTT during the study | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants without clinically significant changes in coagulation throughout the study | 6 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in INR during the study | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in APTT during the study | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants without clinically significant changes in coagulation throughout the study | 2 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in APTT during the study | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in INR during the study | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in INR during the study | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in APTT during the study | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants without clinically significant changes in coagulation throughout the study | 6 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants without clinically significant changes in coagulation throughout the study | 2 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in APTT during the study | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in INR during the study | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants without clinically significant changes in coagulation throughout the study | 6 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in INR during the study | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in APTT during the study | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in INR during the study | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants without clinically significant changes in coagulation throughout the study | 2 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in APTT during the study | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in INR during the study | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in APTT during the study | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants without clinically significant changes in coagulation throughout the study | 6 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants without clinically significant changes in coagulation throughout the study | 2 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in INR during the study | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in APTT during the study | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants without clinically significant changes in coagulation throughout the study | 6 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in INR during the study | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in APTT during the study | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in APTT during the study | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in INR during the study | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants without clinically significant changes in coagulation throughout the study | 2 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in INR during the study | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants without clinically significant changes in coagulation throughout the study | 6 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in APTT during the study | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in APTT during the study | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants without clinically significant changes in coagulation throughout the study | 2 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in INR during the study | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in APTT during the study | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in INR during the study | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants without clinically significant changes in coagulation throughout the study | 6 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in APTT during the study | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in INR during the study | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants without clinically significant changes in coagulation throughout the study | 2 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in APTT during the study | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in INR during the study | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants without clinically significant changes in coagulation throughout the study | 6 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants without clinically significant changes in coagulation throughout the study | 2 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in INR during the study | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study | number of participants with clinically significant changes in APTT during the study | 0 Participants |
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.
Time frame: SAD phase: Screening; Day -1; Day 2 (24 hours); end of study visit (7 to 14 days after last dosing) MAD phase: Screening; Day -1; predose, at Day 3, Day 6, Day 10, Day 13; Day 17; end of study visit (7 to 14 days after last dosing)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haematocrit at one timepoint | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in lymphocytes at one timepoint | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reb blood cells at one timepoint | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in monocytes at one timepoint | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haemoglobin at one timepoint | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in platelets at one timepoint | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Nr of participants without clinically significant changes in hematology param. throughout the study | 6 Participants |
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in neutrophils at one timepoint | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in eosinophils at one timepoint | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reticulocytes at one timepoint | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in white blood cells at one timepoint | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in leucocytes at one timepoint | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in lymphocytes at one timepoint | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in neutrophils at one timepoint | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Nr of participants without clinically significant changes in hematology param. throughout the study | 2 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haemoglobin at one timepoint | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reb blood cells at one timepoint | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in white blood cells at one timepoint | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in leucocytes at one timepoint | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haematocrit at one timepoint | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in platelets at one timepoint | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reticulocytes at one timepoint | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in eosinophils at one timepoint | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in monocytes at one timepoint | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in neutrophils at one timepoint | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in platelets at one timepoint | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reticulocytes at one timepoint | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in eosinophils at one timepoint | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Nr of participants without clinically significant changes in hematology param. throughout the study | 6 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haematocrit at one timepoint | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in white blood cells at one timepoint | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in lymphocytes at one timepoint | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haemoglobin at one timepoint | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in monocytes at one timepoint | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reb blood cells at one timepoint | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in leucocytes at one timepoint | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in eosinophils at one timepoint | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reb blood cells at one timepoint | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Nr of participants without clinically significant changes in hematology param. throughout the study | 2 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haemoglobin at one timepoint | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in platelets at one timepoint | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in neutrophils at one timepoint | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in white blood cells at one timepoint | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haematocrit at one timepoint | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reticulocytes at one timepoint | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in monocytes at one timepoint | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in leucocytes at one timepoint | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in lymphocytes at one timepoint | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haemoglobin at one timepoint | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in monocytes at one timepoint | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in eosinophils at one timepoint | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Nr of participants without clinically significant changes in hematology param. throughout the study | 4 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in leucocytes at one timepoint | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in lymphocytes at one timepoint | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in neutrophils at one timepoint | 1 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reb blood cells at one timepoint | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reticulocytes at one timepoint | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haematocrit at one timepoint | 0 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in white blood cells at one timepoint | 1 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in platelets at one timepoint | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in eosinophils at one timepoint | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in platelets at one timepoint | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Nr of participants without clinically significant changes in hematology param. throughout the study | 2 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haemoglobin at one timepoint | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in white blood cells at one timepoint | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haematocrit at one timepoint | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in leucocytes at one timepoint | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in lymphocytes at one timepoint | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reticulocytes at one timepoint | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in monocytes at one timepoint | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in neutrophils at one timepoint | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reb blood cells at one timepoint | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in neutrophils at one timepoint | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in eosinophils at one timepoint | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in lymphocytes at one timepoint | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in leucocytes at one timepoint | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reticulocytes at one timepoint | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haematocrit at one timepoint | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in white blood cells at one timepoint | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reb blood cells at one timepoint | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in platelets at one timepoint | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in monocytes at one timepoint | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haemoglobin at one timepoint | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Nr of participants without clinically significant changes in hematology param. throughout the study | 6 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in monocytes at one timepoint | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in neutrophils at one timepoint | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in lymphocytes at one timepoint | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haemoglobin at one timepoint | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in platelets at one timepoint | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Nr of participants without clinically significant changes in hematology param. throughout the study | 2 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in white blood cells at one timepoint | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in leucocytes at one timepoint | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reticulocytes at one timepoint | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reb blood cells at one timepoint | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in eosinophils at one timepoint | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haematocrit at one timepoint | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reticulocytes at one timepoint | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in monocytes at one timepoint | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in leucocytes at one timepoint | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haematocrit at one timepoint | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reb blood cells at one timepoint | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in white blood cells at one timepoint | 1 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haemoglobin at one timepoint | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in platelets at one timepoint | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in neutrophils at one timepoint | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Nr of participants without clinically significant changes in hematology param. throughout the study | 5 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in eosinophils at one timepoint | 0 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in lymphocytes at one timepoint | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reb blood cells at one timepoint | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in eosinophils at one timepoint | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haemoglobin at one timepoint | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haematocrit at one timepoint | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in lymphocytes at one timepoint | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in monocytes at one timepoint | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in neutrophils at one timepoint | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in platelets at one timepoint | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reticulocytes at one timepoint | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in leucocytes at one timepoint | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in white blood cells at one timepoint | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Nr of participants without clinically significant changes in hematology param. throughout the study | 2 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reticulocytes at one timepoint | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in monocytes at one timepoint | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Nr of participants without clinically significant changes in hematology param. throughout the study | 6 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in eosinophils at one timepoint | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haemoglobin at one timepoint | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in neutrophils at one timepoint | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in white blood cells at one timepoint | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haematocrit at one timepoint | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reb blood cells at one timepoint | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in platelets at one timepoint | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in leucocytes at one timepoint | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in lymphocytes at one timepoint | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reticulocytes at one timepoint | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Nr of participants without clinically significant changes in hematology param. throughout the study | 2 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in monocytes at one timepoint | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haemoglobin at one timepoint | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in leucocytes at one timepoint | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haematocrit at one timepoint | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in eosinophils at one timepoint | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in lymphocytes at one timepoint | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in white blood cells at one timepoint | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in platelets at one timepoint | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in neutrophils at one timepoint | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reb blood cells at one timepoint | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reticulocytes at one timepoint | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in neutrophils at one timepoint | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reb blood cells at one timepoint | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in monocytes at one timepoint | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in platelets at one timepoint | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in lymphocytes at one timepoint | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haematocrit at one timepoint | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in leucocytes at one timepoint | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haemoglobin at one timepoint | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in white blood cells at one timepoint | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in eosinophils at one timepoint | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Nr of participants without clinically significant changes in hematology param. throughout the study | 6 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in lymphocytes at one timepoint | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haematocrit at one timepoint | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in platelets at one timepoint | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haemoglobin at one timepoint | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Nr of participants without clinically significant changes in hematology param. throughout the study | 2 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reb blood cells at one timepoint | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in eosinophils at one timepoint | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in leucocytes at one timepoint | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in neutrophils at one timepoint | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in white blood cells at one timepoint | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reticulocytes at one timepoint | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in monocytes at one timepoint | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in neutrophils at one timepoint | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in white blood cells at one timepoint | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haemoglobin at one timepoint | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in lymphocytes at one timepoint | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in platelets at one timepoint | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haematocrit at one timepoint | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Nr of participants without clinically significant changes in hematology param. throughout the study | 6 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reb blood cells at one timepoint | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in leucocytes at one timepoint | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reticulocytes at one timepoint | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in eosinophils at one timepoint | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in monocytes at one timepoint | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in neutrophils at one timepoint | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reticulocytes at one timepoint | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in platelets at one timepoint | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reb blood cells at one timepoint | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haematocrit at one timepoint | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Nr of participants without clinically significant changes in hematology param. throughout the study | 2 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in leucocytes at one timepoint | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in monocytes at one timepoint | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haemoglobin at one timepoint | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in white blood cells at one timepoint | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in eosinophils at one timepoint | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in lymphocytes at one timepoint | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in monocytes at one timepoint | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haemoglobin at one timepoint | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in white blood cells at one timepoint | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in eosinophils at one timepoint | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reticulocytes at one timepoint | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in leucocytes at one timepoint | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haematocrit at one timepoint | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in platelets at one timepoint | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in lymphocytes at one timepoint | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reb blood cells at one timepoint | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Nr of participants without clinically significant changes in hematology param. throughout the study | 6 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in neutrophils at one timepoint | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reb blood cells at one timepoint | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in platelets at one timepoint | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haemoglobin at one timepoint | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in reticulocytes at one timepoint | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in haematocrit at one timepoint | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in white blood cells at one timepoint | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in leucocytes at one timepoint | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in eosinophils at one timepoint | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Nr of participants without clinically significant changes in hematology param. throughout the study | 2 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in lymphocytes at one timepoint | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in monocytes at one timepoint | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study | Number of participants with clinically significant changes in neutrophils at one timepoint | 0 Participants |
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.
Time frame: SAD phase (cohorts 1 to 6):Screening, Day -1;Day 1 ;end (7 to 14 days after last dosing) MAD phase: Screening;Day -1; Day 1 ;predose at Day 2, Day 4, Day 6, Day 8, Day 10, Day 12; Day 14 ; Day 17; end (7 to 14 days after last dosing)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants presenting clinically significant change in tympanic body temp. during the study | 0 Participants |
| SAD IFB-088 2.5mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants without clinically significant change in tympanic body temp. throughout the study | 6 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants presenting clinically significant change in tympanic body temp. during the study | 0 Participants |
| SAD Placebo 2.5mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants without clinically significant change in tympanic body temp. throughout the study | 2 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants presenting clinically significant change in tympanic body temp. during the study | 0 Participants |
| SAD IFB-088 5.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants without clinically significant change in tympanic body temp. throughout the study | 6 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants presenting clinically significant change in tympanic body temp. during the study | 0 Participants |
| SAD Placebo 5.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants without clinically significant change in tympanic body temp. throughout the study | 2 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants without clinically significant change in tympanic body temp. throughout the study | 6 Participants |
| SAD IFB-088 10.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants presenting clinically significant change in tympanic body temp. during the study | 0 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants without clinically significant change in tympanic body temp. throughout the study | 2 Participants |
| SAD Placebo 10.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants presenting clinically significant change in tympanic body temp. during the study | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants presenting clinically significant change in tympanic body temp. during the study | 0 Participants |
| SAD IFB-088 20.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants without clinically significant change in tympanic body temp. throughout the study | 6 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants presenting clinically significant change in tympanic body temp. during the study | 0 Participants |
| SAD Placebo 20.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants without clinically significant change in tympanic body temp. throughout the study | 2 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants without clinically significant change in tympanic body temp. throughout the study | 6 Participants |
| SAD IFB-088 40.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants presenting clinically significant change in tympanic body temp. during the study | 0 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants without clinically significant change in tympanic body temp. throughout the study | 2 Participants |
| SAD Placebo 40.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants presenting clinically significant change in tympanic body temp. during the study | 0 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants without clinically significant change in tympanic body temp. throughout the study | 6 Participants |
| SAD IFB-088 60.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants presenting clinically significant change in tympanic body temp. during the study | 0 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants without clinically significant change in tympanic body temp. throughout the study | 2 Participants |
| SAD Placebo 60.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants presenting clinically significant change in tympanic body temp. during the study | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants presenting clinically significant change in tympanic body temp. during the study | 0 Participants |
| MAD IFB-088 15.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants without clinically significant change in tympanic body temp. throughout the study | 6 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants presenting clinically significant change in tympanic body temp. during the study | 0 Participants |
| MAD Placebo 15.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants without clinically significant change in tympanic body temp. throughout the study | 2 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants presenting clinically significant change in tympanic body temp. during the study | 0 Participants |
| MAD IFB-088 30.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants without clinically significant change in tympanic body temp. throughout the study | 6 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants presenting clinically significant change in tympanic body temp. during the study | 0 Participants |
| MAD Placebo 30.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants without clinically significant change in tympanic body temp. throughout the study | 2 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants presenting clinically significant change in tympanic body temp. during the study | 0 Participants |
| MAD IFB-088 50.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants without clinically significant change in tympanic body temp. throughout the study | 6 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants presenting clinically significant change in tympanic body temp. during the study | 0 Participants |
| MAD Placebo 50.0mg | Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study | Nr of participants without clinically significant change in tympanic body temp. throughout the study | 2 Participants |
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).
Time frame: Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SAD IFB-088 5.0mg | Pharmacokinetic: Apparent Total Body Clearance (CL/F) | 736 L/h | Standard Deviation 43 |
| SAD Placebo 5.0mg | Pharmacokinetic: Apparent Total Body Clearance (CL/F) | 1146 L/h | Standard Deviation 45.1 |
| SAD IFB-088 10.0mg | Pharmacokinetic: Apparent Total Body Clearance (CL/F) | 1279 L/h | Standard Deviation 13.9 |
| SAD Placebo 10.0mg | Pharmacokinetic: Apparent Total Body Clearance (CL/F) | 1388 L/h | Standard Deviation 61.6 |
| SAD IFB-088 20.0mg | Pharmacokinetic: Apparent Total Body Clearance (CL/F) | 926 L/h | Standard Deviation 34.7 |
| SAD Placebo 20.0mg | Pharmacokinetic: Apparent Total Body Clearance (CL/F) | 826 L/h | Standard Deviation 38.3 |
| SAD IFB-088 40.0mg | Pharmacokinetic: Apparent Total Body Clearance (CL/F) | 843 L/h | Standard Deviation 28 |
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).
Time frame: Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SAD IFB-088 5.0mg | Pharmacokinetic: Apparent Volume of Distribution (Vd/F) | 5093 L | Standard Deviation 16.9 |
| SAD Placebo 5.0mg | Pharmacokinetic: Apparent Volume of Distribution (Vd/F) | 10055 L | Standard Deviation 33.2 |
| SAD IFB-088 10.0mg | Pharmacokinetic: Apparent Volume of Distribution (Vd/F) | 10408 L | Standard Deviation 16.4 |
| SAD Placebo 10.0mg | Pharmacokinetic: Apparent Volume of Distribution (Vd/F) | 10550 L | Standard Deviation 65.5 |
| SAD IFB-088 20.0mg | Pharmacokinetic: Apparent Volume of Distribution (Vd/F) | 8916 L | Standard Deviation 41.1 |
| SAD Placebo 20.0mg | Pharmacokinetic: Apparent Volume of Distribution (Vd/F) | 6860 L | Standard Deviation 43 |
| SAD IFB-088 40.0mg | Pharmacokinetic: Apparent Volume of Distribution (Vd/F) | 7042 L | Standard Deviation 54.5 |
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).
Time frame: Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SAD IFB-088 2.5mg | Pharmacokinetic: Area Under Plasma Concentration-time Curve From Hour 0 to Last Sample With Measurable Plasma Concentrations (AUClast) | 2.25 ng*h/mL | Standard Deviation 50.6 |
| SAD Placebo 2.5mg | Pharmacokinetic: Area Under Plasma Concentration-time Curve From Hour 0 to Last Sample With Measurable Plasma Concentrations (AUClast) | 3.80 ng*h/mL | Standard Deviation 95.2 |
| SAD IFB-088 5.0mg | Pharmacokinetic: Area Under Plasma Concentration-time Curve From Hour 0 to Last Sample With Measurable Plasma Concentrations (AUClast) | 12.5 ng*h/mL | Standard Deviation 47.9 |
| SAD Placebo 5.0mg | Pharmacokinetic: Area Under Plasma Concentration-time Curve From Hour 0 to Last Sample With Measurable Plasma Concentrations (AUClast) | 17.4 ng*h/mL | Standard Deviation 41.7 |
| SAD IFB-088 10.0mg | Pharmacokinetic: Area Under Plasma Concentration-time Curve From Hour 0 to Last Sample With Measurable Plasma Concentrations (AUClast) | 27.4 ng*h/mL | Standard Deviation 32.5 |
| SAD Placebo 10.0mg | Pharmacokinetic: Area Under Plasma Concentration-time Curve From Hour 0 to Last Sample With Measurable Plasma Concentrations (AUClast) | 51.1 ng*h/mL | Standard Deviation 40 |
| SAD IFB-088 20.0mg | Pharmacokinetic: Area Under Plasma Concentration-time Curve From Hour 0 to Last Sample With Measurable Plasma Concentrations (AUClast) | 18.7 ng*h/mL | Standard Deviation 49.5 |
| SAD Placebo 20.0mg | Pharmacokinetic: Area Under Plasma Concentration-time Curve From Hour 0 to Last Sample With Measurable Plasma Concentrations (AUClast) | 40.8 ng*h/mL | Standard Deviation 35.7 |
| SAD IFB-088 40.0mg | Pharmacokinetic: Area Under Plasma Concentration-time Curve From Hour 0 to Last Sample With Measurable Plasma Concentrations (AUClast) | 77.2 ng*h/mL | Standard Deviation 48.8 |
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).
Time frame: Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SAD IFB-088 2.5mg | Pharmacokinetic: Maximum Observed Plasma Concentration (Cmax) | Cmax Dose 1 | 0.54 ng/ml | Standard Deviation 34.5 |
| SAD Placebo 2.5mg | Pharmacokinetic: Maximum Observed Plasma Concentration (Cmax) | Cmax Dose 2 | 0.37 ng/ml | Standard Deviation 59.7 |
| SAD Placebo 2.5mg | Pharmacokinetic: Maximum Observed Plasma Concentration (Cmax) | Cmax Dose 1 | 0.45 ng/ml | Standard Deviation 62.3 |
| SAD IFB-088 5.0mg | Pharmacokinetic: Maximum Observed Plasma Concentration (Cmax) | Cmax Dose 2 | 1.13 ng/ml | Standard Deviation 44.2 |
| SAD IFB-088 5.0mg | Pharmacokinetic: Maximum Observed Plasma Concentration (Cmax) | Cmax Dose 1 | 1.19 ng/ml | Standard Deviation 75.5 |
| SAD Placebo 5.0mg | Pharmacokinetic: Maximum Observed Plasma Concentration (Cmax) | Cmax Dose 1 | 1.39 ng/ml | Standard Deviation 16.3 |
| SAD Placebo 5.0mg | Pharmacokinetic: Maximum Observed Plasma Concentration (Cmax) | Cmax Dose 2 | 1.52 ng/ml | Standard Deviation 34.3 |
| SAD IFB-088 10.0mg | Pharmacokinetic: Maximum Observed Plasma Concentration (Cmax) | Cmax Dose 1 | 2.93 ng/ml | Standard Deviation 35.2 |
| SAD IFB-088 10.0mg | Pharmacokinetic: Maximum Observed Plasma Concentration (Cmax) | Cmax Dose 2 | 2.39 ng/ml | Standard Deviation 31.2 |
| SAD Placebo 10.0mg | Pharmacokinetic: Maximum Observed Plasma Concentration (Cmax) | Cmax Dose 2 | 4.52 ng/ml | Standard Deviation 50.6 |
| SAD Placebo 10.0mg | Pharmacokinetic: Maximum Observed Plasma Concentration (Cmax) | Cmax Dose 1 | 4.26 ng/ml | Standard Deviation 46.3 |
| SAD IFB-088 20.0mg | Pharmacokinetic: Maximum Observed Plasma Concentration (Cmax) | Cmax Dose 1 | 1.70 ng/ml | Standard Deviation 87.1 |
| SAD IFB-088 20.0mg | Pharmacokinetic: Maximum Observed Plasma Concentration (Cmax) | Cmax Dose 2 | 1.61 ng/ml | Standard Deviation 47.2 |
| SAD Placebo 20.0mg | Pharmacokinetic: Maximum Observed Plasma Concentration (Cmax) | Cmax Dose 1 | 2.52 ng/ml | Standard Deviation 54 |
| SAD Placebo 20.0mg | Pharmacokinetic: Maximum Observed Plasma Concentration (Cmax) | Cmax Dose 2 | 3.58 ng/ml | Standard Deviation 41.1 |
| SAD IFB-088 40.0mg | Pharmacokinetic: Maximum Observed Plasma Concentration (Cmax) | Cmax Dose 2 | 6.92 ng/ml | Standard Deviation 52.3 |
| SAD IFB-088 40.0mg | Pharmacokinetic: Maximum Observed Plasma Concentration (Cmax) | Cmax Dose 1 | 4.38 ng/ml | Standard Deviation 49.8 |
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
Time frame: Starting 1 hour prior to dosing on Day 1 and until 48 hours after last dosing (Day 16)
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SAD Placebo 2.5mg | Pharmacokinetic: Percent of Drug Recovered in Urine (Ae %Dose) | 0.52 mg/day | Standard Deviation 67.7 |
| SAD IFB-088 5.0mg | Pharmacokinetic: Percent of Drug Recovered in Urine (Ae %Dose) | 0.55 mg/day | Standard Deviation 49.6 |
| SAD Placebo 5.0mg | Pharmacokinetic: Percent of Drug Recovered in Urine (Ae %Dose) | 0.61 mg/day | Standard Deviation 46.2 |
| SAD IFB-088 10.0mg | Pharmacokinetic: Percent of Drug Recovered in Urine (Ae %Dose) | 0.44 mg/day | Standard Deviation 44.9 |
| SAD Placebo 10.0mg | Pharmacokinetic: Percent of Drug Recovered in Urine (Ae %Dose) | 0.29 mg/day | Standard Deviation 39.7 |
| SAD IFB-088 20.0mg | Pharmacokinetic: Percent of Drug Recovered in Urine (Ae %Dose) | 0.61 mg/day | Standard Deviation 52.5 |
| SAD Placebo 20.0mg | Pharmacokinetic: Percent of Drug Recovered in Urine (Ae %Dose) | 0.74 mg/day | Standard Deviation 56.8 |
| SAD IFB-088 40.0mg | Pharmacokinetic: Percent of Drug Recovered in Urine (Ae %Dose) | 0.63 mg/day | Standard Deviation 39.7 |
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
Time frame: Starting 1 hour prior to dosing on Day 1 and until 48 hours after last dosing (Day 16)
Population: Data were not collected for the SAD IFB-088 2.5 mg cohort
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SAD Placebo 2.5mg | Pharmacokinetic: Renal Clearance (CLr) | 167 mL/min | Standard Deviation 55.8 |
| SAD IFB-088 5.0mg | Pharmacokinetic: Renal Clearance (CLr) | 75.3 mL/min | Standard Deviation 44.6 |
| SAD Placebo 5.0mg | Pharmacokinetic: Renal Clearance (CLr) | 117 mL/min | Standard Deviation 22.3 |
| SAD IFB-088 10.0mg | Pharmacokinetic: Renal Clearance (CLr) | 106 mL/min | Standard Deviation 32.4 |
| SAD Placebo 10.0mg | Pharmacokinetic: Renal Clearance (CLr) | 60.5 mL/min | Standard Deviation 37.6 |
| SAD IFB-088 20.0mg | Pharmacokinetic: Renal Clearance (CLr) | 76.6 mL/min | Standard Deviation 34 |
| SAD Placebo 20.0mg | Pharmacokinetic: Renal Clearance (CLr) | 84.4 mL/min | Standard Deviation 45 |
| SAD IFB-088 40.0mg | Pharmacokinetic: Renal Clearance (CLr) | 66.2 mL/min | Standard Deviation 36.4 |
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).
Time frame: Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SAD IFB-088 2.5mg | Pharmacokinetic: Terminal Half-life (t1/2) | 4.64 h | Standard Deviation 33.3 |
| SAD Placebo 2.5mg | Pharmacokinetic: Terminal Half-life (t1/2) | 4.61 h | Standard Deviation 56.5 |
| SAD IFB-088 5.0mg | Pharmacokinetic: Terminal Half-life (t1/2) | 5.92 h | Standard Deviation 33.8 |
| SAD Placebo 5.0mg | Pharmacokinetic: Terminal Half-life (t1/2) | 6.21 h | Standard Deviation 26.9 |
| SAD IFB-088 10.0mg | Pharmacokinetic: Terminal Half-life (t1/2) | 5.76 h | Standard Deviation 10.8 |
| SAD Placebo 10.0mg | Pharmacokinetic: Terminal Half-life (t1/2) | 5.17 h | Standard Deviation 11.8 |
| SAD IFB-088 20.0mg | Pharmacokinetic: Terminal Half-life (t1/2) | 6.97 h | Standard Deviation 33.1 |
| SAD Placebo 20.0mg | Pharmacokinetic: Terminal Half-life (t1/2) | 5.70 h | Standard Deviation 22.9 |
| SAD IFB-088 40.0mg | Pharmacokinetic: Terminal Half-life (t1/2) | 6.34 h | Standard Deviation 28.7 |
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).
Time frame: Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SAD IFB-088 2.5mg | Pharmacokinetic: Time to Reach the Maximum Concentration in Plasma (Tmax) | Tmax Dose 1 | 1.5 h |
| SAD Placebo 2.5mg | Pharmacokinetic: Time to Reach the Maximum Concentration in Plasma (Tmax) | Tmax Dose 2 | 2.0 h |
| SAD Placebo 2.5mg | Pharmacokinetic: Time to Reach the Maximum Concentration in Plasma (Tmax) | Tmax Dose 1 | 1.5 h |
| SAD IFB-088 5.0mg | Pharmacokinetic: Time to Reach the Maximum Concentration in Plasma (Tmax) | Tmax Dose 2 | 2.0 h |
| SAD IFB-088 5.0mg | Pharmacokinetic: Time to Reach the Maximum Concentration in Plasma (Tmax) | Tmax Dose 1 | 2.0 h |
| SAD Placebo 5.0mg | Pharmacokinetic: Time to Reach the Maximum Concentration in Plasma (Tmax) | Tmax Dose 2 | 2.0 h |
| SAD Placebo 5.0mg | Pharmacokinetic: Time to Reach the Maximum Concentration in Plasma (Tmax) | Tmax Dose 1 | 2.0 h |
| SAD IFB-088 10.0mg | Pharmacokinetic: Time to Reach the Maximum Concentration in Plasma (Tmax) | Tmax Dose 1 | 1.0 h |
| SAD IFB-088 10.0mg | Pharmacokinetic: Time to Reach the Maximum Concentration in Plasma (Tmax) | Tmax Dose 2 | 1.0 h |
| SAD Placebo 10.0mg | Pharmacokinetic: Time to Reach the Maximum Concentration in Plasma (Tmax) | Tmax Dose 1 | 2.0 h |
| SAD Placebo 10.0mg | Pharmacokinetic: Time to Reach the Maximum Concentration in Plasma (Tmax) | Tmax Dose 2 | 2.0 h |
| SAD IFB-088 20.0mg | Pharmacokinetic: Time to Reach the Maximum Concentration in Plasma (Tmax) | Tmax Dose 1 | 2.0 h |
| SAD IFB-088 20.0mg | Pharmacokinetic: Time to Reach the Maximum Concentration in Plasma (Tmax) | Tmax Dose 2 | 2.0 h |
| SAD Placebo 20.0mg | Pharmacokinetic: Time to Reach the Maximum Concentration in Plasma (Tmax) | Tmax Dose 1 | 2.0 h |
| SAD Placebo 20.0mg | Pharmacokinetic: Time to Reach the Maximum Concentration in Plasma (Tmax) | Tmax Dose 2 | 2.0 h |
| SAD IFB-088 40.0mg | Pharmacokinetic: Time to Reach the Maximum Concentration in Plasma (Tmax) | Tmax Dose 2 | 2.0 h |
| SAD IFB-088 40.0mg | Pharmacokinetic: Time to Reach the Maximum Concentration in Plasma (Tmax) | Tmax Dose 1 | 2.0 h |
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
Time frame: MAD phase: Day 1 and Day 14 at predose, 1.5 hours and 24 hours
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
Time frame: SAD phase: Day 1 at predose, 1.5 hours and 24 hours