Study To Evaluate The Pharmacokinetic, Safety And Tolerability Of Single Or Multiple Subcutaneous Doses of Recifercept

A Phase 1, Randomized, Parallel-Group Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Single or Multiple Subcutaneous Doses of Lyophilized Formulation of Recifercept in Healthy Participants

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Recifercept; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles-capitale, Région DE
    • Brussels, Bruxelles-capitale, Région DE, Belgium, B-1070
      • Brussels Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
• Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Dose; Repeated multiple doses	Drug: Recifercept; recifercept powder for solution for injection; Other Names: PF-07256472
Placebo Comparator: placebo; Repeated multiple doses	Other: Placebo; solution for injection
Experimental: High Dose; Repeated multiple doses	Drug: Recifercept; recifercept powder for solution for injection; Other Names: PF-07256472

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	6 months post-dose

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2020
• Primary Completion (Actual): August 3, 2021
• Study Completion (Actual): November 26, 2021

Study Registration Dates

• First Submitted: September 4, 2020
• First Submitted That Met QC Criteria: September 4, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Actual): January 10, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: C4181004; 2020-000545-14 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No