Singe Dose Study of PF- 06946860 in Healthy Adult Japanese Participants

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: PF-06946860; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials LLC-Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key 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.

Key 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF-06946860; Single subcutaneous administration of PF-06946860	Biological: PF-06946860; PF-06946860 administered subcutaneously
Placebo Comparator: Placebo; Single subcutaneous administration of placebo	Other: Placebo; Placebo administered subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of participants experiencing AE	Up to 20 weeks post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed PF-06946860 Concentration (Cmax)		Up to 20 weeks post-dose
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
PF-06946860 Half-Life (t1/2)	Time measured for the PF-06946860 concentration to decrease by one half.	Up to 20 weeks post-dose, as data permit
Incidence of development of ADA, and if necessary NAb, against PF-06946860		Up to 20 weeks post-dose, as data permit

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2019
• Primary Completion (Actual): January 10, 2020
• Study Completion (Actual): January 10, 2020

Study Registration Dates

• First Submitted: June 3, 2019
• First Submitted That Met QC Criteria: June 3, 2019
• First Posted (Actual): June 5, 2019

Study Record Updates

• Last Update Posted (Actual): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 28, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: C3651002; FIP (Other Identifier: Alias Study Number); Japanese Ph1 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No