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Recifercept

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Jan 10, 2022

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

Clinical trial landscape

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 being developed by Pfizer, Inc. It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers to evaluate its pharmacokinetics, safety, and tolerability following single or multiple subcutaneous doses.

Who makes Recifercept?

Recifercept is being developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's safety and tolerability in healthy subjects.

What phase is Recifercept in?

Recifercept is in Phase 1 clinical development. A Phase 1 trial has been completed, which enrolled 24 healthy volunteers. The study was randomized, double-blind, and placebo-controlled, and it took place in Belgium.

What clinical trials is Recifercept in?

Recifercept has one completed Phase 1 clinical trial, identified as NCT04543344. The study evaluated the pharmacokinetic, safety, and tolerability of single or multiple subcutaneous doses of Recifercept in healthy participants aged 21 years and older.

Is Recifercept FDA approved?

Recifercept is not FDA approved. It is an investigational drug that is still in clinical development. The completed Phase 1 trial focused on healthy volunteers to assess safety and tolerability, and the drug has not yet been studied in patient populations for any specific disease.