A PHASE 1, RANDOMIZED, DOUBLE BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE-DOSE, SUBCUTANEOUS ADMINISTRATION OF PF-06946860 TO HEALTHY ADULT JAPANESE PARTICIPANTS

Pfizer1 site in 1 country8 target enrollmentJuly 8, 2019

ConditionsHealthy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy
Sponsor: Pfizer
Enrollment: 8
Locations: 1
Primary Endpoint: Incidence of participants experiencing AE
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of PF-06946860 in healthy adult Japanese participants following single dose administration.

Registry

clinicaltrials.gov

Start Date

July 8, 2019

End Date

January 10, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive
•Body mass index (BMI) within 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb)
•Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
•Subjects enrolling as Japanese must have four biologically Japanese grandparents born in Japan.

Exclusion Criteria

•Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing.
•History of allergic reactions to diagnostic or therapeutic protein or human albumin.
•History of recurrent infections or active infection within 28 days of screening.
•Exposure to live vaccines within 28 days of screening.
•History of regular alcohol consumption or positive drug test
•Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of IP (whichever is longer).
•Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 28 days after the last dose.
•Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose

Outcomes

Primary Outcomes

Incidence of participants experiencing AE

Time Frame: Up to 20 weeks post-dose

Secondary Outcomes

Maximum Observed PF-06946860 Concentration (Cmax)(Up to 20 weeks post-dose)
PF-06946860 Half-Life (t1/2)(Up to 20 weeks post-dose, as data permit)
Area Under the Curve From Time Zero to Last Quantifiable PF-06946860 Concentration (AUClast)(Up to 20 weeks post-dose)
Time to Reach Maximum Observed PF-06946860 Concentration (Tmax)(Up to 20 weeks post-dose)
Incidence of development of ADA, and if necessary NAb, against PF-06946860(Up to 20 weeks post-dose, as data permit)