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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Other: Placebo; Drug: Recifercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT04543344

2020-000545-14 (EudraCT Number)

C4181004

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 3 patient groups, including a placebo group

Low Dose

Experimental group

Description:

Repeated multiple doses

Treatment:

Drug: Recifercept

placebo

Placebo Comparator group

Description:

Repeated multiple doses

Treatment:

Other: Placebo

High Dose

Experimental group

Description:

Repeated multiple doses

Treatment:

Drug: Recifercept