Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000545-14 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This will be a single center, randomized, parallel group, repeated dose study of recifercept (Cohort 1 and Cohort 2) or placebo (only in Cohort 1) in approximately 18 healthy participants, using 2 cohorts (N = 9) at two dose levels of recifercept.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose | Experimental | Repeated multiple doses |
|
| placebo | Placebo Comparator | Repeated multiple doses |
|
| High Dose | Experimental | Repeated multiple doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recifercept | Drug | recifercept powder for solution for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) | 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). | 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 312 and 504 hours post-dose |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) | Area under the concentration curve from time 0 to end of dosing interval (AUCtau) | 0, 2, 4, 6, 12, 24, 48 and 72 hours post-dose |
| Maximum Observed Plasma Concentration (Cmax) | Maximum Observed Plasma Concentration directly from data | 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 312 and 504 hours post-dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Time to reach Cmax | 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 312 and 504 hours post-dose |
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 312 and 504 hours post-dose |
| Accumulation Ratio (Rac) | 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). | 0, 2, 4, 6, 12, 24, 48 and 72 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Anti-drug antibodies (ADA) | Incidence of participants who are ADA positive | 6 months post-dose |
| Incidence of Neutralizing antibodies (NAb) | Incidence of participants who are NAb positive |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brussels Clinical Research Unit | Brussels | Bruxelles-capitale, Région de | B-1070 | Belgium |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Only cohort 1 of the study is blinded.
| Placebo | Other | solution for injection |
|
| 6 months post-dose |