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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Recifercept
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |