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Recifercept

Phase 2

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Jan 10, 2022

Recifercept development status

Highest phase Phase 2 (NCT04638153)
Phase scored for PFEPhase 1
Registered trials 5 across 1 sponsor since Sep 2020

Recifercept target and mechanism

ModalitySmall molecule

Also known as PF-07256472

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Recifercept clinical trials

Recifercept · 1 trial · 1 indication

Phase 1 1
NCT04543344Study To Evaluate The Pharmacokinetic, Safety And Tolerability Of Single Or Multiple Subcutaneous Doses of ReciferceptHealthy
COMPLETED24 Analytics
PHASE1COMPLETED
Study To Evaluate The Pharmacokinetic, Safety And Tolerability Of Single Or Multiple Subcutaneous Doses of Recifercept
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Study Endpoints

Primary Endpoints

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 312 and 504 hours post-dose

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 Curve From Time Zero to End of Dosing Interval (AUCtau)
0, 2, 4, 6, 12, 24, 48 and 72 hours post-dose

Area under the concentration curve from time 0 to end of dosing interval (AUCtau)

Maximum Observed Plasma Concentration (Cmax)
0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 312 and 504 hours post-dose

Maximum Observed Plasma Concentration directly from data

Time to Reach Maximum Observed Plasma Concentration (Tmax)
0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 312 and 504 hours post-dose

Time to reach Cmax

Plasma Decay Half-Life (t1/2)
0, 2, 4, 6, 12, 24, 48, 72, 120, 168, 216, 312 and 504 hours post-dose

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Accumulation Ratio (Rac)
0, 2, 4, 6, 12, 24, 48 and 72 hours post-dose

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).

Secondary Endpoints

Incidence of Anti-drug antibodies (ADA)
6 months post-dose
Incidence of Neutralizing antibodies (NAb)
6 months post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Low DoseEXPERIMENTALRepeated multiple doses
placeboPLACEBO_COMPARATORRepeated multiple doses
High DoseEXPERIMENTALRepeated multiple doses

Interventions

NameTypeDescription
ReciferceptDRUGrecifercept powder for solution for injection
PlaceboOTHERsolution for injection
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Eligibility Criteria

Age Range21 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:Belgium
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Frequently asked questions about Recifercept

What is Recifercept?

Recifercept is an investigational small molecule developed by Pfizer, Inc. (ticker PFE). It has been studied in a Phase 1 clinical trial involving healthy adult volunteers. The specific disease or condition it is intended to treat has not been disclosed.

Who makes Recifercept?

Recifercept is being developed by Pfizer, Inc., which trades under the ticker symbol PFE. Pfizer sponsored the Phase 1 clinical study of the drug. No partnership or licensing arrangement for Recifercept has been disclosed.

What phase is Recifercept in?

Recifercept is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is Recifercept in?

Recifercept has been evaluated in one completed Phase 1 trial, NCT04543344, titled a study to evaluate the pharmacokinetic, safety and tolerability of single or multiple subcutaneous doses of Recifercept. The trial enrolled 24 healthy volunteers in Belgium and was randomized, double-blind, and placebo-controlled.

How was the Phase 1 trial of Recifercept designed?

The Phase 1 trial of Recifercept, NCT04543344, was a randomized, double-blind, placebo-controlled study of single or multiple subcutaneous doses. It enrolled 24 healthy volunteers of all sexes, aged 21 years and older, at sites in Belgium. The study has been completed.

Is Recifercept approved by the FDA?

Recifercept is not approved. It is an investigational small molecule in Phase 1 clinical development, and its only recorded trial has been completed. Pfizer, Inc. (ticker PFE) is the developer. No regulatory approval for any indication has been announced.