Trial Outcomes & Findings for A Combined SAD and MAD Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of IFB-088 (NCT NCT03610334)
NCT ID: NCT03610334
Last Updated: 2022-01-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
72 participants
Primary outcome timeframe
SAD & MAD phases: Screening visit to End of study visit (7 to 14 days after last dosing) + 30 days
Results posted on
2022-01-26
Participant Flow
Participant milestones
| Measure |
SAD IFB-088 2.5 mg
A single daily dose of IFB-088 2.5 mg is administered to 6 healthy volunteers
|
SAD Placebo 2.5mg
A single daily dose of placebo (microcristalline cellusose) 2.5 mg is administered to 2 healthy volunteers
|
SAD IFB-088 5.0mg
Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the previous period.
A single daily dose of IFB-088 5.0 mg is administered to 6 healthy volunteers, in two intakes of 2.5mg, separated by 12h.
|
SAD Placebo 5.0mg
Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the previous period.
A single daily dose of placebo (microcrystalline cellulose) 5.0 mg is administered to 2 healthy volunteers, in two intakes of 2.5mg, separated by 12h.
|
SAD IFB-088 10.0mg
Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the previous period.
A single daily dose of IFB-088 10.0 mg is administered to 6 healthy volunteers, in two intakes of 5.0mg, separated by 12h.
|
SAD Placebo 10.0mg
Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the previous period.
A single daily dose of placebo (microcrystalline cellusose) 10.0 mg is administered to 2 healthy volunteers, in two intakes of 5.0mg, separated by 12h.
|
SAD IFB-088 20.0mg
Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the previous period.
A single daily dose of IFB-088 20.0 mg is administered to 6 healthy volunteers, in two intakes of 10.0mg, separated by 12h.
|
SAD Placebo 20.0mg
Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the previous period.
A single daily dose of placebo (microcrystalline cellusose) 20.0 mg is administered to 2 healthy volunteers, in two intakes of 10.0mg, separated by 12h.
|
SAD IFB-088 40.0mg
Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the previous period.
A single daily dose of IFB-088 40.0 mg is administered to 6 healthy volunteers, in two intakes of 20.mg, separated by 12h.
|
SAD Placebo 40.0mg
Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the previous period.
A single daily dose of placebo (microcrystalline cellusose) 40.0 mg is administered to 2 healthy volunteers, in two intakes of 20.0mg, separated by 12h.
|
SAD IFB-088 60.0mg
Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the previous period.
A single daily dose of IFB-088 60.0 mg is administered to 6 healthy volunteers, in two intakes of 30.0mg, separated by 12h.
|
SAD Placebo 60.0mg
Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the previous period.
A single daily dose of placebo (microcrystalline cellusose) 60.0 mg is administered to 2 healthy volunteers, in two intakes of 30.0mg, separated by 12h.
|
MAD IFB-088 15.0mg
Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the Single Ascending Dose Study.
A single dose of IFB-088 15.0 mg is administered to 6 healthy volunteers, during 14 days
|
MAD Placebo 15.0mg
Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the Single Ascending Dose Study.
A single dose of placebo (microcrystalline cellulose) 15.0 mg is administered to 2 healthy volunteers, during 14 days
|
MAD IFB-088 30.0mg
Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the previous period.
A dose of IFB-088 30.0 mg is administered in two intakes of 15.0mg, administered at 12hours of interval, to 6 healthy volunteers, during 14 days.
|
MAD Placebo 30.0mg
Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the previous period.
A dose of placebo (microcrystalline cellulose) 30.0 mg is administered in two intakes of 15.0mg, administered at 12hours of interval, to 2 healthy volunteers, during 14 days.
|
MAD IFB-088 50.0mg
Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the previous period.
A dose of IFB-088 50.0 mg is administered in two intakes of 25.0mg, administered at 12hours of interval, to 6 healthy volunteers, during 14 days.
|
MAD Placebo 50.0mg
Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the previous period.
A dose of placebo (microcrystalline cellulose) 50.0 mg is administered in two intakes of 25.0mg, administered at 12hours of interval, to 2 healthy volunteers, during 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Period 1: 2.5mg (1 Day)
STARTED
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6
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2
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Period 1: 2.5mg (1 Day)
COMPLETED
|
6
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2
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Period 1: 2.5mg (1 Day)
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Period 2: 5.0mg (1 Day)
STARTED
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6
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2
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6
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2
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Period 2: 5.0mg (1 Day)
COMPLETED
|
6
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2
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6
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2
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Period 2: 5.0mg (1 Day)
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Period 3: 10.0mg (1 Day)
STARTED
|
6
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2
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6
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2
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6
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2
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Period 3: 10.0mg (1 Day)
COMPLETED
|
6
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2
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6
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2
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6
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2
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Period 3: 10.0mg (1 Day)
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Period 4: 20.0mg (1 Day)
STARTED
|
6
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2
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6
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2
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6
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2
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6
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2
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Period 4: 20.0mg (1 Day)
COMPLETED
|
6
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2
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6
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2
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6
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2
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6
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2
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Period 4: 20.0mg (1 Day)
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Period 5: 40.0mg (1 Day)
STARTED
|
6
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2
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6
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2
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6
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2
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6
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2
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6
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2
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0
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0
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0
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0
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0
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0
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0
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0
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Period 5: 40.0mg (1 Day)
COMPLETED
|
6
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2
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6
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2
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6
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2
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6
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2
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6
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2
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0
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0
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0
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0
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0
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0
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0
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0
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Period 5: 40.0mg (1 Day)
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Period 6: 60.0mg (1 Day)
STARTED
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6
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2
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6
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2
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6
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2
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6
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2
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6
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2
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6
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2
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0
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0
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0
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0
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0
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0
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Period 6: 60.0mg (1 Day)
COMPLETED
|
6
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2
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6
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2
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6
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2
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6
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2
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6
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2
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6
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2
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0
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0
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0
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0
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0
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0
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Period 6: 60.0mg (1 Day)
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Period 7: 15.0mg (Day 1 to 14)
STARTED
|
6
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2
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6
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2
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6
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2
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6
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2
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6
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2
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6
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2
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6
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2
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0
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0
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0
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0
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Period 7: 15.0mg (Day 1 to 14)
COMPLETED
|
6
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2
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6
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2
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6
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2
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6
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2
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6
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2
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6
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2
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6
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2
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0
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0
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0
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0
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Period 7: 15.0mg (Day 1 to 14)
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Period 8: 30.0mg (Day 1 to 14)
STARTED
|
6
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2
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6
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2
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6
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2
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6
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2
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6
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2
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6
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2
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6
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2
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6
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2
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0
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0
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Period 8: 30.0mg (Day 1 to 14)
COMPLETED
|
6
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2
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6
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2
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6
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2
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6
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2
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6
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2
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6
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2
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6
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2
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6
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2
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0
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0
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Period 8: 30.0mg (Day 1 to 14)
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Period 9: 50.0mg (Day 1 to 14)
STARTED
|
6
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2
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6
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2
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6
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2
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6
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2
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6
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2
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6
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2
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6
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2
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6
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2
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6
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2
|
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Period 9: 50.0mg (Day 1 to 14)
COMPLETED
|
6
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2
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6
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2
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6
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2
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6
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2
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6
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2
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6
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2
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6
|
2
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6
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2
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6
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2
|
|
Period 9: 50.0mg (Day 1 to 14)
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
2 parts: SAD: 48 subjects and MAD: 24 subjects
Baseline characteristics by cohort
| Measure |
Cohort 1: SAD IFB-088 2.5mg
n=6 Participants
a single daily dose of 2.5mg IFB-088 in oral capsule, is administered in the morning (8:00am), in one intake
|
Cohort 2: SAD IFB-088 5.0mg
n=6 Participants
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)
|
Cohort 3: SAD IFB-088 10.0mg
n=6 Participants
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)
|
Cohort 4: SAD IFB-088 20.0mg
n=6 Participants
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)
|
Cohort 5: SAD IFB-088 40.0mg
n=6 Participants
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)
|
Cohort 6: SAD IFB-088 60.0mg
n=6 Participants
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)
|
Cohort 7: MAD IFB-088 15.0mg
n=6 Participants
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
|
Cohort 8: MAD IFB-088 30.0mg
n=6 Participants
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
|
Cohort 9: MAD IFB-088 50.0mg
n=6 Participants
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
|
SAD Placebo Group
n=12 Participants
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)
|
MAD Placebo Group
n=6 Participants
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
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
subject age
|
31.0 Year
n=99 Participants • 2 parts: SAD: 48 subjects and MAD: 24 subjects
|
25.5 Year
n=107 Participants • 2 parts: SAD: 48 subjects and MAD: 24 subjects
|
27.5 Year
n=206 Participants • 2 parts: SAD: 48 subjects and MAD: 24 subjects
|
24.7 Year
n=7 Participants • 2 parts: SAD: 48 subjects and MAD: 24 subjects
|
24.5 Year
n=31 Participants • 2 parts: SAD: 48 subjects and MAD: 24 subjects
|
25.5 Year
n=30 Participants • 2 parts: SAD: 48 subjects and MAD: 24 subjects
|
27.0 Year
n=3 Participants • 2 parts: SAD: 48 subjects and MAD: 24 subjects
|
31.7 Year
n=6 Participants • 2 parts: SAD: 48 subjects and MAD: 24 subjects
|
31.0 Year
n=114 Participants • 2 parts: SAD: 48 subjects and MAD: 24 subjects
|
26.5 Year
2 parts: SAD: 48 subjects and MAD: 24 subjects
|
31.7 Year
n=19 Participants • 2 parts: SAD: 48 subjects and MAD: 24 subjects
|
26.5 Year
n=4 Participants • 2 parts: SAD: 48 subjects and MAD: 24 subjects
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
12 Participants
|
6 Participants
n=19 Participants
|
72 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
12 Participants
|
6 Participants
n=19 Participants
|
72 Participants
n=4 Participants
|
|
Region of Enrollment
France
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
6 participants
n=206 Participants
|
6 participants
n=7 Participants
|
6 participants
n=31 Participants
|
6 participants
n=30 Participants
|
6 participants
n=3 Participants
|
6 participants
n=6 Participants
|
6 participants
n=114 Participants
|
12 participants
|
6 participants
n=19 Participants
|
72 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: SAD & MAD phases: Screening visit to End of study visit (7 to 14 days after last dosing) + 30 daysPopulation: 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.
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.
Outcome measures
| Measure |
SAD IFB-088 5.0mg
n=2 Participants
Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 10.0mg
n=6 Participants
Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 20.0mg
n=2 Participants
Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 2.5mg
n=6 Participants
healthy volunteers received IFB-088 2.5mg once daily, in the morning.
|
SAD IFB-088 10.0mg
n=6 Participants
healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD Placebo 10.0mg
n=2 Participants
healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD IFB-088 20.0mg
n=6 Participants
healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD Placebo 20.0mg
n=2 Participants
healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD IFB-088 40.0mg
n=6 Participants
healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD Placebo 40.0mg
n=2 Participants
healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD IFB-088 60.0mg
n=6 Participants
healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
SAD Placebo 60.0mg
n=2 Participants
healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
MAD IFB-088 15.0mg
n=6 Participants
healthy volunteers received IFB-088 15.0mg once daily, in the morning, during 14 days.
|
MAD Placebo 15.0mg
n=2 Participants
healthy volunteers received placebo 15.0mg once daily, in the morning, during 14 days.
|
MAD IFB-088 30.0mg
n=6 Participants
healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 30.0mg
n=2 Participants
healthy volunteers received placebo 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD IFB-088 50.0mg
n=6 Participants
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 50.0mg
n=2 Participants
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events Per Group
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
SAD IFB-088 5.0mg
n=2 Participants
Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 10.0mg
n=6 Participants
Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 20.0mg
n=2 Participants
Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 2.5mg
n=6 Participants
healthy volunteers received IFB-088 2.5mg once daily, in the morning.
|
SAD IFB-088 10.0mg
n=6 Participants
healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD Placebo 10.0mg
n=2 Participants
healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD IFB-088 20.0mg
n=6 Participants
healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD Placebo 20.0mg
n=2 Participants
healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD IFB-088 40.0mg
n=6 Participants
healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD Placebo 40.0mg
n=2 Participants
healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD IFB-088 60.0mg
n=6 Participants
healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
SAD Placebo 60.0mg
n=2 Participants
healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
MAD IFB-088 15.0mg
n=6 Participants
healthy volunteers received IFB-088 15.0mg once daily, in the morning, during 14 days.
|
MAD Placebo 15.0mg
n=2 Participants
healthy volunteers received placebo 15.0mg once daily, in the morning, during 14 days.
|
MAD IFB-088 30.0mg
n=6 Participants
healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 30.0mg
n=2 Participants
healthy volunteers received placebo 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD IFB-088 50.0mg
n=6 Participants
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 50.0mg
n=2 Participants
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Change in Concomitant Medications
add-on: acetaminophen 1000mg 1/day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change in Concomitant Medications
add-on: naproxen 550mg bid
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change in Concomitant Medications
add-on: fexofenadine 180mg 1/day
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change in Concomitant Medications
add-on: desloratadine 5 mg as needed
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change in Concomitant Medications
number of participants without change
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
SAD IFB-088 5.0mg
n=6 Participants
Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 10.0mg
n=6 Participants
Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 20.0mg
n=6 Participants
Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 2.5mg
n=6 Participants
healthy volunteers received IFB-088 2.5mg once daily, in the morning.
|
SAD IFB-088 10.0mg
n=6 Participants
healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD Placebo 10.0mg
n=6 Participants
healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD IFB-088 20.0mg
n=6 Participants
healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD Placebo 20.0mg
n=6 Participants
healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD IFB-088 40.0mg
n=6 Participants
healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD Placebo 40.0mg
healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD IFB-088 60.0mg
healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
SAD Placebo 60.0mg
healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
MAD IFB-088 15.0mg
healthy volunteers received IFB-088 15.0mg once daily, in the morning, during 14 days.
|
MAD Placebo 15.0mg
healthy volunteers received placebo 15.0mg once daily, in the morning, during 14 days.
|
MAD IFB-088 30.0mg
healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 30.0mg
healthy volunteers received placebo 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD IFB-088 50.0mg
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 50.0mg
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic: Maximum Observed Plasma Concentration (Cmax)
Cmax Dose 1
|
0.45 ng/ml
Standard Deviation 62.3
|
1.19 ng/ml
Standard Deviation 75.5
|
1.39 ng/ml
Standard Deviation 16.3
|
0.54 ng/ml
Standard Deviation 34.5
|
2.93 ng/ml
Standard Deviation 35.2
|
4.26 ng/ml
Standard Deviation 46.3
|
1.70 ng/ml
Standard Deviation 87.1
|
2.52 ng/ml
Standard Deviation 54.0
|
4.38 ng/ml
Standard Deviation 49.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic: Maximum Observed Plasma Concentration (Cmax)
Cmax Dose 2
|
0.37 ng/ml
Standard Deviation 59.7
|
1.13 ng/ml
Standard Deviation 44.2
|
1.52 ng/ml
Standard Deviation 34.3
|
—
|
2.39 ng/ml
Standard Deviation 31.2
|
4.52 ng/ml
Standard Deviation 50.6
|
1.61 ng/ml
Standard Deviation 47.2
|
3.58 ng/ml
Standard Deviation 41.1
|
6.92 ng/ml
Standard Deviation 52.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
SAD IFB-088 5.0mg
n=6 Participants
Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 10.0mg
n=6 Participants
Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 20.0mg
n=6 Participants
Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 2.5mg
n=6 Participants
healthy volunteers received IFB-088 2.5mg once daily, in the morning.
|
SAD IFB-088 10.0mg
n=6 Participants
healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD Placebo 10.0mg
n=6 Participants
healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD IFB-088 20.0mg
n=6 Participants
healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD Placebo 20.0mg
n=6 Participants
healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD IFB-088 40.0mg
n=6 Participants
healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD Placebo 40.0mg
healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD IFB-088 60.0mg
healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
SAD Placebo 60.0mg
healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
MAD IFB-088 15.0mg
healthy volunteers received IFB-088 15.0mg once daily, in the morning, during 14 days.
|
MAD Placebo 15.0mg
healthy volunteers received placebo 15.0mg once daily, in the morning, during 14 days.
|
MAD IFB-088 30.0mg
healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 30.0mg
healthy volunteers received placebo 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD IFB-088 50.0mg
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 50.0mg
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic: Time to Reach the Maximum Concentration in Plasma (Tmax)
Tmax Dose 1
|
1.5 h
Interval 0.7 to 2.0
|
2.0 h
Interval 1.0 to 4.0
|
2.0 h
Interval 1.0 to 3.0
|
1.5 h
Interval 1.0 to 1.5
|
1.0 h
Interval 0.7 to 2.0
|
2.0 h
Interval 1.0 to 3.0
|
2.0 h
Interval 1.0 to 2.0
|
2.0 h
Interval 1.0 to 3.0
|
2.0 h
Interval 1.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Pharmacokinetic: Time to Reach the Maximum Concentration in Plasma (Tmax)
Tmax Dose 2
|
2.0 h
Interval 1.0 to 4.0
|
2.0 h
Interval 2.0 to 2.0
|
2.0 h
Interval 1.0 to 2.0
|
—
|
1.0 h
Interval 1.0 to 2.0
|
2.0 h
Interval 0.5 to 4.0
|
2.0 h
Interval 2.0 to 3.0
|
2.0 h
Interval 2.0 to 3.0
|
2.0 h
Interval 1.0 to 3.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
SAD IFB-088 5.0mg
n=6 Participants
Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 10.0mg
n=6 Participants
Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 20.0mg
n=6 Participants
Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 2.5mg
n=6 Participants
healthy volunteers received IFB-088 2.5mg once daily, in the morning.
|
SAD IFB-088 10.0mg
n=6 Participants
healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD Placebo 10.0mg
n=6 Participants
healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD IFB-088 20.0mg
n=6 Participants
healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD Placebo 20.0mg
n=6 Participants
healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD IFB-088 40.0mg
n=6 Participants
healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD Placebo 40.0mg
healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD IFB-088 60.0mg
healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
SAD Placebo 60.0mg
healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
MAD IFB-088 15.0mg
healthy volunteers received IFB-088 15.0mg once daily, in the morning, during 14 days.
|
MAD Placebo 15.0mg
healthy volunteers received placebo 15.0mg once daily, in the morning, during 14 days.
|
MAD IFB-088 30.0mg
healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 30.0mg
healthy volunteers received placebo 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD IFB-088 50.0mg
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 50.0mg
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic: Terminal Half-life (t1/2)
|
4.61 h
Standard Deviation 56.5
|
5.92 h
Standard Deviation 33.8
|
6.21 h
Standard Deviation 26.9
|
4.64 h
Standard Deviation 33.3
|
5.76 h
Standard Deviation 10.8
|
5.17 h
Standard Deviation 11.8
|
6.97 h
Standard Deviation 33.1
|
5.70 h
Standard Deviation 22.9
|
6.34 h
Standard Deviation 28.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
SAD IFB-088 5.0mg
n=6 Participants
Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 10.0mg
n=6 Participants
Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 20.0mg
n=6 Participants
Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 2.5mg
n=6 Participants
healthy volunteers received IFB-088 2.5mg once daily, in the morning.
|
SAD IFB-088 10.0mg
n=6 Participants
healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD Placebo 10.0mg
n=6 Participants
healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD IFB-088 20.0mg
n=6 Participants
healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD Placebo 20.0mg
n=6 Participants
healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD IFB-088 40.0mg
n=6 Participants
healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD Placebo 40.0mg
healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD IFB-088 60.0mg
healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
SAD Placebo 60.0mg
healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
MAD IFB-088 15.0mg
healthy volunteers received IFB-088 15.0mg once daily, in the morning, during 14 days.
|
MAD Placebo 15.0mg
healthy volunteers received placebo 15.0mg once daily, in the morning, during 14 days.
|
MAD IFB-088 30.0mg
healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 30.0mg
healthy volunteers received placebo 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD IFB-088 50.0mg
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 50.0mg
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
12.5 ng*h/mL
Standard Deviation 47.9
|
17.4 ng*h/mL
Standard Deviation 41.7
|
2.25 ng*h/mL
Standard Deviation 50.6
|
27.4 ng*h/mL
Standard Deviation 32.5
|
51.1 ng*h/mL
Standard Deviation 40.0
|
18.7 ng*h/mL
Standard Deviation 49.5
|
40.8 ng*h/mL
Standard Deviation 35.7
|
77.2 ng*h/mL
Standard Deviation 48.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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
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).
Outcome measures
| Measure |
SAD IFB-088 5.0mg
Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 10.0mg
n=6 Participants
Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 20.0mg
n=6 Participants
Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 2.5mg
healthy volunteers received IFB-088 2.5mg once daily, in the morning.
|
SAD IFB-088 10.0mg
n=6 Participants
healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD Placebo 10.0mg
n=6 Participants
healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD IFB-088 20.0mg
n=6 Participants
healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD Placebo 20.0mg
n=6 Participants
healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD IFB-088 40.0mg
n=6 Participants
healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD Placebo 40.0mg
healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD IFB-088 60.0mg
healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
SAD Placebo 60.0mg
healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
MAD IFB-088 15.0mg
healthy volunteers received IFB-088 15.0mg once daily, in the morning, during 14 days.
|
MAD Placebo 15.0mg
healthy volunteers received placebo 15.0mg once daily, in the morning, during 14 days.
|
MAD IFB-088 30.0mg
healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 30.0mg
healthy volunteers received placebo 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD IFB-088 50.0mg
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 50.0mg
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic: Apparent Volume of Distribution (Vd/F)
|
—
|
5093 L
Standard Deviation 16.9
|
10055 L
Standard Deviation 33.2
|
—
|
10408 L
Standard Deviation 16.4
|
10550 L
Standard Deviation 65.5
|
8916 L
Standard Deviation 41.1
|
6860 L
Standard Deviation 43.0
|
7042 L
Standard Deviation 54.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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
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).
Outcome measures
| Measure |
SAD IFB-088 5.0mg
Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 10.0mg
n=6 Participants
Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 20.0mg
n=6 Participants
Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 2.5mg
healthy volunteers received IFB-088 2.5mg once daily, in the morning.
|
SAD IFB-088 10.0mg
n=6 Participants
healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD Placebo 10.0mg
n=6 Participants
healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD IFB-088 20.0mg
n=6 Participants
healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD Placebo 20.0mg
n=6 Participants
healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD IFB-088 40.0mg
n=6 Participants
healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD Placebo 40.0mg
healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD IFB-088 60.0mg
healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
SAD Placebo 60.0mg
healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
MAD IFB-088 15.0mg
healthy volunteers received IFB-088 15.0mg once daily, in the morning, during 14 days.
|
MAD Placebo 15.0mg
healthy volunteers received placebo 15.0mg once daily, in the morning, during 14 days.
|
MAD IFB-088 30.0mg
healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 30.0mg
healthy volunteers received placebo 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD IFB-088 50.0mg
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 50.0mg
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic: Apparent Total Body Clearance (CL/F)
|
—
|
736 L/h
Standard Deviation 43.0
|
1146 L/h
Standard Deviation 45.1
|
—
|
1279 L/h
Standard Deviation 13.9
|
1388 L/h
Standard Deviation 61.6
|
926 L/h
Standard Deviation 34.7
|
826 L/h
Standard Deviation 38.3
|
843 L/h
Standard Deviation 28.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
SAD IFB-088 5.0mg
n=6 Participants
Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 10.0mg
n=6 Participants
Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 20.0mg
n=6 Participants
Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 2.5mg
healthy volunteers received IFB-088 2.5mg once daily, in the morning.
|
SAD IFB-088 10.0mg
n=6 Participants
healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD Placebo 10.0mg
n=6 Participants
healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD IFB-088 20.0mg
n=6 Participants
healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD Placebo 20.0mg
n=6 Participants
healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD IFB-088 40.0mg
n=6 Participants
healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD Placebo 40.0mg
healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD IFB-088 60.0mg
healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
SAD Placebo 60.0mg
healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
MAD IFB-088 15.0mg
healthy volunteers received IFB-088 15.0mg once daily, in the morning, during 14 days.
|
MAD Placebo 15.0mg
healthy volunteers received placebo 15.0mg once daily, in the morning, during 14 days.
|
MAD IFB-088 30.0mg
healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 30.0mg
healthy volunteers received placebo 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD IFB-088 50.0mg
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 50.0mg
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic: Renal Clearance (CLr)
|
167 mL/min
Standard Deviation 55.8
|
75.3 mL/min
Standard Deviation 44.6
|
117 mL/min
Standard Deviation 22.3
|
—
|
106 mL/min
Standard Deviation 32.4
|
60.5 mL/min
Standard Deviation 37.6
|
76.6 mL/min
Standard Deviation 34.0
|
84.4 mL/min
Standard Deviation 45.0
|
66.2 mL/min
Standard Deviation 36.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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
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
Outcome measures
| Measure |
SAD IFB-088 5.0mg
n=6 Participants
Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 10.0mg
n=6 Participants
Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 20.0mg
n=6 Participants
Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 2.5mg
healthy volunteers received IFB-088 2.5mg once daily, in the morning.
|
SAD IFB-088 10.0mg
n=6 Participants
healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD Placebo 10.0mg
n=6 Participants
healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD IFB-088 20.0mg
n=6 Participants
healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD Placebo 20.0mg
n=6 Participants
healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD IFB-088 40.0mg
n=6 Participants
healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD Placebo 40.0mg
healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD IFB-088 60.0mg
healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
SAD Placebo 60.0mg
healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
MAD IFB-088 15.0mg
healthy volunteers received IFB-088 15.0mg once daily, in the morning, during 14 days.
|
MAD Placebo 15.0mg
healthy volunteers received placebo 15.0mg once daily, in the morning, during 14 days.
|
MAD IFB-088 30.0mg
healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 30.0mg
healthy volunteers received placebo 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD IFB-088 50.0mg
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 50.0mg
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic: Percent of Drug Recovered in Urine (Ae %Dose)
|
0.52 mg/day
Standard Deviation 67.7
|
0.55 mg/day
Standard Deviation 49.6
|
0.61 mg/day
Standard Deviation 46.2
|
—
|
0.44 mg/day
Standard Deviation 44.9
|
0.29 mg/day
Standard Deviation 39.7
|
0.61 mg/day
Standard Deviation 52.5
|
0.74 mg/day
Standard Deviation 56.8
|
0.63 mg/day
Standard Deviation 39.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
SAD IFB-088 5.0mg
n=2 Participants
Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 10.0mg
n=6 Participants
Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 20.0mg
n=2 Participants
Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 2.5mg
n=6 Participants
healthy volunteers received IFB-088 2.5mg once daily, in the morning.
|
SAD IFB-088 10.0mg
n=6 Participants
healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD Placebo 10.0mg
n=2 Participants
healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD IFB-088 20.0mg
n=6 Participants
healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD Placebo 20.0mg
n=2 Participants
healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD IFB-088 40.0mg
n=6 Participants
healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD Placebo 40.0mg
n=2 Participants
healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD IFB-088 60.0mg
n=6 Participants
healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
SAD Placebo 60.0mg
n=2 Participants
healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
MAD IFB-088 15.0mg
n=6 Participants
healthy volunteers received IFB-088 15.0mg once daily, in the morning, during 14 days.
|
MAD Placebo 15.0mg
n=2 Participants
healthy volunteers received placebo 15.0mg once daily, in the morning, during 14 days.
|
MAD IFB-088 30.0mg
n=6 Participants
healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 30.0mg
n=2 Participants
healthy volunteers received placebo 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD IFB-088 50.0mg
n=6 Participants
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 50.0mg
n=2 Participants
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Change in Physical Evaluation During the Study
cardiavascular system
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Change in Physical Evaluation During the Study
digestive system
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Change in Physical Evaluation During the Study
general condition
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Change in Physical Evaluation During the Study
liver and biliary tract
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Change in Physical Evaluation During the Study
lymphatic system
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Change in Physical Evaluation During the Study
muco-cutaneous system
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Change in Physical Evaluation During the Study
ENT system
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Change in Physical Evaluation During the Study
respiratory system
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Change in Physical Evaluation During the Study
visual system
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Change in Physical Evaluation During the Study
number of participants with no clinically significant changes
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
SAD IFB-088 5.0mg
n=2 Participants
Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 10.0mg
n=6 Participants
Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 20.0mg
n=2 Participants
Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 2.5mg
n=6 Participants
healthy volunteers received IFB-088 2.5mg once daily, in the morning.
|
SAD IFB-088 10.0mg
n=6 Participants
healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD Placebo 10.0mg
n=2 Participants
healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD IFB-088 20.0mg
n=6 Participants
healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD Placebo 20.0mg
n=2 Participants
healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD IFB-088 40.0mg
n=6 Participants
healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD Placebo 40.0mg
n=2 Participants
healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD IFB-088 60.0mg
n=6 Participants
healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
SAD Placebo 60.0mg
n=2 Participants
healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
MAD IFB-088 15.0mg
n=6 Participants
healthy volunteers received IFB-088 15.0mg once daily, in the morning, during 14 days.
|
MAD Placebo 15.0mg
n=2 Participants
healthy volunteers received placebo 15.0mg once daily, in the morning, during 14 days.
|
MAD IFB-088 30.0mg
n=6 Participants
healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 30.0mg
n=2 Participants
healthy volunteers received placebo 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD IFB-088 50.0mg
n=6 Participants
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 50.0mg
n=2 Participants
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Change in Physiological Parameters During the Study
number of participants without clinically significant changes
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Change in Physiological Parameters During the Study
Number of subjects with clinically significant change in weight
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Change in Physiological Parameters During the Study
Number of participants with clinically significant change in BMI
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
SAD IFB-088 5.0mg
n=2 Participants
Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 10.0mg
n=6 Participants
Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 20.0mg
n=2 Participants
Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 2.5mg
n=6 Participants
healthy volunteers received IFB-088 2.5mg once daily, in the morning.
|
SAD IFB-088 10.0mg
n=6 Participants
healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD Placebo 10.0mg
n=2 Participants
healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD IFB-088 20.0mg
n=6 Participants
healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD Placebo 20.0mg
n=2 Participants
healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD IFB-088 40.0mg
n=6 Participants
healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD Placebo 40.0mg
n=2 Participants
healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD IFB-088 60.0mg
n=6 Participants
healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
SAD Placebo 60.0mg
n=2 Participants
healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
MAD IFB-088 15.0mg
n=6 Participants
healthy volunteers received IFB-088 15.0mg once daily, in the morning, during 14 days.
|
MAD Placebo 15.0mg
n=2 Participants
healthy volunteers received placebo 15.0mg once daily, in the morning, during 14 days.
|
MAD IFB-088 30.0mg
n=6 Participants
healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 30.0mg
n=2 Participants
healthy volunteers received placebo 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD IFB-088 50.0mg
n=6 Participants
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 50.0mg
n=2 Participants
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
6 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
SAD IFB-088 5.0mg
n=2 Participants
Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 10.0mg
n=6 Participants
Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 20.0mg
n=2 Participants
Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 2.5mg
n=6 Participants
healthy volunteers received IFB-088 2.5mg once daily, in the morning.
|
SAD IFB-088 10.0mg
n=6 Participants
healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD Placebo 10.0mg
n=2 Participants
healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD IFB-088 20.0mg
n=6 Participants
healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD Placebo 20.0mg
n=2 Participants
healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD IFB-088 40.0mg
n=6 Participants
healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD Placebo 40.0mg
n=2 Participants
healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD IFB-088 60.0mg
n=6 Participants
healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
SAD Placebo 60.0mg
n=2 Participants
healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
MAD IFB-088 15.0mg
n=6 Participants
healthy volunteers received IFB-088 15.0mg once daily, in the morning, during 14 days.
|
MAD Placebo 15.0mg
n=2 Participants
healthy volunteers received placebo 15.0mg once daily, in the morning, during 14 days.
|
MAD IFB-088 30.0mg
n=6 Participants
healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 30.0mg
n=2 Participants
healthy volunteers received placebo 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD IFB-088 50.0mg
n=6 Participants
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 50.0mg
n=2 Participants
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
6 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
SAD IFB-088 5.0mg
n=2 Participants
Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 10.0mg
n=6 Participants
Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 20.0mg
n=2 Participants
Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 2.5mg
n=6 Participants
healthy volunteers received IFB-088 2.5mg once daily, in the morning.
|
SAD IFB-088 10.0mg
n=6 Participants
healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD Placebo 10.0mg
n=2 Participants
healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD IFB-088 20.0mg
n=6 Participants
healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD Placebo 20.0mg
n=2 Participants
healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD IFB-088 40.0mg
n=6 Participants
healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD Placebo 40.0mg
n=2 Participants
healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD IFB-088 60.0mg
n=6 Participants
healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
SAD Placebo 60.0mg
n=2 Participants
healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
MAD IFB-088 15.0mg
n=6 Participants
healthy volunteers received IFB-088 15.0mg once daily, in the morning, during 14 days.
|
MAD Placebo 15.0mg
n=2 Participants
healthy volunteers received placebo 15.0mg once daily, in the morning, during 14 days.
|
MAD IFB-088 30.0mg
n=6 Participants
healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 30.0mg
n=2 Participants
healthy volunteers received placebo 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD IFB-088 50.0mg
n=6 Participants
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 50.0mg
n=2 Participants
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
6 Participants
|
2 Participants
|
6 Participants
|
4 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
SAD IFB-088 5.0mg
n=2 Participants
Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 10.0mg
n=6 Participants
Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 20.0mg
n=2 Participants
Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 2.5mg
n=6 Participants
healthy volunteers received IFB-088 2.5mg once daily, in the morning.
|
SAD IFB-088 10.0mg
n=6 Participants
healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD Placebo 10.0mg
n=2 Participants
healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD IFB-088 20.0mg
n=6 Participants
healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD Placebo 20.0mg
n=2 Participants
healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD IFB-088 40.0mg
n=6 Participants
healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD Placebo 40.0mg
n=2 Participants
healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD IFB-088 60.0mg
n=6 Participants
healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
SAD Placebo 60.0mg
n=2 Participants
healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
MAD IFB-088 15.0mg
n=6 Participants
healthy volunteers received IFB-088 15.0mg once daily, in the morning, during 14 days.
|
MAD Placebo 15.0mg
n=2 Participants
healthy volunteers received placebo 15.0mg once daily, in the morning, during 14 days.
|
MAD IFB-088 30.0mg
n=6 Participants
healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 30.0mg
n=2 Participants
healthy volunteers received placebo 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD IFB-088 50.0mg
n=6 Participants
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 50.0mg
n=2 Participants
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
6 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
SAD IFB-088 5.0mg
n=2 Participants
Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 10.0mg
n=6 Participants
Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 20.0mg
n=2 Participants
Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 2.5mg
n=6 Participants
healthy volunteers received IFB-088 2.5mg once daily, in the morning.
|
SAD IFB-088 10.0mg
n=6 Participants
healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD Placebo 10.0mg
n=2 Participants
healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD IFB-088 20.0mg
n=6 Participants
healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD Placebo 20.0mg
n=2 Participants
healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD IFB-088 40.0mg
n=6 Participants
healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD Placebo 40.0mg
n=2 Participants
healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD IFB-088 60.0mg
n=6 Participants
healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
SAD Placebo 60.0mg
n=2 Participants
healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
MAD IFB-088 15.0mg
n=6 Participants
healthy volunteers received IFB-088 15.0mg once daily, in the morning, during 14 days.
|
MAD Placebo 15.0mg
n=2 Participants
healthy volunteers received placebo 15.0mg once daily, in the morning, during 14 days.
|
MAD IFB-088 30.0mg
n=6 Participants
healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 30.0mg
n=2 Participants
healthy volunteers received placebo 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD IFB-088 50.0mg
n=6 Participants
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 50.0mg
n=2 Participants
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
5 Participants
|
1 Participants
|
6 Participants
|
5 Participants
|
2 Participants
|
6 Participants
|
1 Participants
|
6 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
SAD IFB-088 5.0mg
n=2 Participants
Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 10.0mg
n=6 Participants
Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 20.0mg
n=2 Participants
Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 2.5mg
n=6 Participants
healthy volunteers received IFB-088 2.5mg once daily, in the morning.
|
SAD IFB-088 10.0mg
n=6 Participants
healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD Placebo 10.0mg
n=2 Participants
healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD IFB-088 20.0mg
n=6 Participants
healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD Placebo 20.0mg
n=2 Participants
healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD IFB-088 40.0mg
n=6 Participants
healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD Placebo 40.0mg
n=2 Participants
healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD IFB-088 60.0mg
n=6 Participants
healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
SAD Placebo 60.0mg
n=2 Participants
healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
MAD IFB-088 15.0mg
n=6 Participants
healthy volunteers received IFB-088 15.0mg once daily, in the morning, during 14 days.
|
MAD Placebo 15.0mg
n=2 Participants
healthy volunteers received placebo 15.0mg once daily, in the morning, during 14 days.
|
MAD IFB-088 30.0mg
n=6 Participants
healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 30.0mg
n=2 Participants
healthy volunteers received placebo 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD IFB-088 50.0mg
n=6 Participants
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 50.0mg
n=2 Participants
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
00 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
6 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
SAD IFB-088 5.0mg
n=2 Participants
Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 10.0mg
n=6 Participants
Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 20.0mg
n=2 Participants
Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm
IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours
|
SAD IFB-088 2.5mg
n=6 Participants
healthy volunteers received IFB-088 2.5mg once daily, in the morning.
|
SAD IFB-088 10.0mg
n=6 Participants
healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD Placebo 10.0mg
n=2 Participants
healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.
|
SAD IFB-088 20.0mg
n=6 Participants
healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD Placebo 20.0mg
n=2 Participants
healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.
|
SAD IFB-088 40.0mg
n=6 Participants
healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD Placebo 40.0mg
n=2 Participants
healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.
|
SAD IFB-088 60.0mg
n=6 Participants
healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
SAD Placebo 60.0mg
n=2 Participants
healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.
|
MAD IFB-088 15.0mg
n=6 Participants
healthy volunteers received IFB-088 15.0mg once daily, in the morning, during 14 days.
|
MAD Placebo 15.0mg
n=2 Participants
healthy volunteers received placebo 15.0mg once daily, in the morning, during 14 days.
|
MAD IFB-088 30.0mg
n=6 Participants
healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 30.0mg
n=2 Participants
healthy volunteers received placebo 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.
|
MAD IFB-088 50.0mg
n=6 Participants
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
MAD Placebo 50.0mg
n=2 Participants
healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
|
6 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: SAD phase: Day 1 at predose, 1.5 hours and 24 hoursBlood samples will be collected and stored in a biobank to explore potential biomarkers that remain to be identified
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: MAD phase: Day 1 and Day 14 at predose, 1.5 hours and 24 hoursBlood samples will be collected and stored in a biobank to explore potential biomarkers that remain to be identified
Outcome measures
Outcome data not reported
Adverse Events
SAD IFB-088 2.5mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SAD IFB-088 5.0mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SAD IFB-088 10.0mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SAD IFB-088 20.0mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SAD IFB-088 40.0mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SAD IFB-088 60.0mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
SAD Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
MAD IFB-088 15.0mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
MAD IFB-088 30.0mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
MAD IFB-088 50.0mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
MAD Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SAD IFB-088 2.5mg
n=6 participants at risk
cohort 1: single daily dose of 2.5mg IFB-088 oral capsule, administered in the morning (8:00am), in one intake
|
SAD IFB-088 5.0mg
n=6 participants at risk
cohort 2: single daily dose of 5.0mg IFB-088 oral capsule, administered in two intakes of 2.5mg, 12 hours apart, in the morning (8:00am), and in the evening (8:00pm)
|
SAD IFB-088 10.0mg
n=6 participants at risk
cohort 3: single daily dose of 10.0mg IFB-088 oral capsule, administered in two intakes of 5.0mg, 12 hours apart, in the morning (8:00am), and in the evening (8:00pm)
|
SAD IFB-088 20.0mg
n=6 participants at risk
cohort 4: single daily dose of 20.0mg IFB-088 oral capsule, administered in two intakes of 10.0mg, 12 hours apart, in the morning (8:00am), and in the evening (8:00pm)
|
SAD IFB-088 40.0mg
n=6 participants at risk
cohort 5: single daily dose of 40.0mg IFB-088 oral capsule, administered in two intakes of 20.0mg, 12 hours apart, in the morning (8:00am), and in the evening (8:00pm)
|
SAD IFB-088 60.0mg
n=6 participants at risk
cohort 6: single daily dose of 60.0mg IFB-088 oral capsule, administered in two intakes of 30.0mg, 12 hours apart, in the morning (8:00am), and in the evening (8:00pm)
|
SAD Placebo
n=12 participants at risk
(cohort 1 to 6): single daily dose of placebo oral capsule, administered in two intakes (except for the first SAD dose that is administered in one intake), at 12h intervals, in the morning (8:00am) and in the evening (8:00pm)
|
MAD IFB-088 15.0mg
n=6 participants at risk
cohort 7: subject taking 15.0mg of IFB-088 oral capsule divided in two dose of 7.5mg, at an interval of 12h, in the morning (8:00am), and in the evening (8:00pm), for 14 days.
|
MAD IFB-088 30.0mg
n=6 participants at risk
cohort 8: subject taking 30.0mg of IFB-088 oral capsule divided in two dose of 15.0mg, at an interval of 12h, in the morning (8:00am), and in the evening (8:00pm), for 14 days.
|
MAD IFB-088 50.0mg
n=6 participants at risk
cohort 9: subject taking 50.0mg of IFB-088 oral capsule divided in two dose of 25.0mg, at an interval of 12h, in the morning (8:00am), and in the evening (8:00pm), for 14 days.
|
MAD Placebo
n=6 participants at risk
(cohort 7 to 9): subject taking placebo oral capsule divided in two doses, at an interval of 12h, in the morning (8:00am), and in the evning (8:00pm), for 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
haematuria
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/12 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
16.7%
1/6 • Number of events 1 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
|
Vascular disorders
orthostatic hypotension
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/12 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
16.7%
1/6 • Number of events 1 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
|
Renal and urinary disorders
nephrolithiasis
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/12 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
16.7%
1/6 • Number of events 1 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
|
Nervous system disorders
headache
|
16.7%
1/6 • Number of events 1 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
16.7%
1/6 • Number of events 1 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/12 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
33.3%
2/6 • Number of events 2 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
16.7%
1/6 • Number of events 1 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
|
General disorders
pyrexia
|
16.7%
1/6 • Number of events 1 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/12 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
|
General disorders
catheter site related reaction
|
16.7%
1/6 • Number of events 1 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/12 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
|
Metabolism and nutrition disorders
hypertriglyceridemia
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
16.7%
1/6 • Number of events 1 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
16.7%
1/6 • Number of events 1 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
33.3%
2/6 • Number of events 2 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
16.7%
2/12 • Number of events 2 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
|
General disorders
influenza like illness
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
16.7%
1/6 • Number of events 1 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/12 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
|
Infections and infestations
nasopharyngitis
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
16.7%
1/6 • Number of events 1 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/12 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
|
Gastrointestinal disorders
toothache
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
16.7%
1/6 • Number of events 1 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/12 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
16.7%
1/6 • Number of events 1 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
|
Injury, poisoning and procedural complications
joint injury
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
16.7%
1/6 • Number of events 1 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/12 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
|
Gastrointestinal disorders
diarrhoea
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
16.7%
1/6 • Number of events 1 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
16.7%
1/6 • Number of events 1 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/12 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
|
Respiratory, thoracic and mediastinal disorders
rhinitis allergic
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
16.7%
1/6 • Number of events 1 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/12 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
|
Ear and labyrinth disorders
ear pain
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/12 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
16.7%
1/6 • Number of events 1 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
|
Renal and urinary disorders
pollakyuria
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/12 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
16.7%
1/6 • Number of events 1 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/12 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
33.3%
2/6 • Number of events 2 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
|
Nervous system disorders
paraesthesia
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/12 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
16.7%
1/6 • Number of events 1 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/12 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
16.7%
1/6 • Number of events 1 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
|
Nervous system disorders
presyncope
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/12 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
16.7%
1/6 • Number of events 1 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
0.00%
0/6 • 18 months
Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
|
Additional Information
Dr Anne Visbecq (Chief Medical Officer)
Inflectis Bioscience
Phone: 0630632020
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results.
- Publication restrictions are in place
Restriction type: OTHER