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

Pfizer1 site in 1 country63 target enrollmentJuly 30, 2018

ConditionsHealthy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy
Sponsor: Pfizer
Enrollment: 63
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 subjects following single ascending doses This is the first clinical study of PF-06946860.

Registry

clinicaltrials.gov

Start Date

July 30, 2018

End Date

September 18, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Sequential

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 9 weeks post dose

Secondary Outcomes

Maximum Observed Plasma Concentration (Cmax)(Baseline, up to 9 weeks post dose, as data permit)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(Baseline, up to 9 weeks post dose, as data permit)
Time to Reach Maximum Observed Plasma Concentration (Tmax)(Baseline, up to 9 weeks post dose, as data permit)
Incidence of development of ADA, and if necessary NAb, against PF-06946860(Baseline, up to 9 weeks post-dose, as data permit)
Plasma Decay Half-Life (t1/2)(Baseline, up to 9 weeks post dose, as data permit)