Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04543344 | Study To Evaluate The Pharmacokinetic, Safety And Tolerability Of Single Or Multiple Subcutaneous Doses of Recifercept | PHASE1 | COMPLETED | 24 | — | — | Sep 17, 2020 | Nov 26, 2021 | Jan 10, 2022 | 1 | Belgium |
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Area under the concentration curve from time 0 to end of dosing interval (AUCtau)
Maximum Observed Plasma Concentration directly from data
Time to reach Cmax
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Accumulation ratio was calculated as, Rac obtained from Area Under the Concentration Time Curve (AUC) from time 0-t (Day X) divided by AUC from time 0-t (Day 1).
| Arm | Type | Description |
|---|---|---|
| Low Dose | EXPERIMENTAL | Repeated multiple doses |
| placebo | PLACEBO_COMPARATOR | Repeated multiple doses |
| High Dose | EXPERIMENTAL | Repeated multiple doses |
| Name | Type | Description |
|---|---|---|
| Recifercept | DRUG | recifercept powder for solution for injection |
| Placebo | OTHER | solution for injection |
Inclusion Criteria: * Male participants and female participants of nonchildbearing potential * Participants who are overtly healthy * Capable of giving signed informed consent Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastroint...