A Phase 1 interventional study of Recifercept and Placebo in Healthy, sponsored by Pfizer. Completed at 1 site in Belgium. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-10.
Sponsored by Pfizer · Phase 1, Interventional, and Treatment
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.
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Repeated multiple doses
Drug: Recifercept
Repeated multiple doses
Other: Placebo
Repeated multiple doses
Drug: Recifercept
recifercept powder for solution for injection
Also known as: PF-07256472
solution for injection
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).
Time frame: 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)
Time frame: 0, 2, 4, 6, 12, 24, 48 and 72 hours post-dose
Maximum Observed Plasma Concentration (Cmax)
Maximum Observed Plasma Concentration directly from data
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: 0, 2, 4, 6, 12, 24, 48 and 72 hours post-dose
Incidence of Anti-drug antibodies (ADA)
Incidence of participants who are ADA positive
Time frame: 6 months post-dose
Incidence of Neutralizing antibodies (NAb)
Incidence of participants who are NAb positive
Time frame: 6 months post-dose
Plan to share: No — 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.
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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