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

Pfizer24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

ReciferceptDRUG

recifercept powder for solution for injection

PlaceboOTHER

solution for injection

Eligibility

Sex: ALLMin age: 21 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Brussels Clinical Research Unit

Brussels, Bruxelles-capitale, Région de, Belgium

Outcomes

Primary Outcomes

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

Secondary Outcomes

Incidence of Anti-drug antibodies (ADA)

Data from ClinicalTrials.gov

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