Singe Dose, First in Human Study of PF- 06946860 in Healthy Adult Subjects

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Pfizer New Haven Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 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: Sequential Assignment
• Masking: Triple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Single subcutaneous administration of PF-06946860 at planned dose level 0.1 mg, or placebo	Biological: PF-06946860; PF-06946860 administered subcutaneously; Other: Placebo; Placebo, administered subcutaneously
Experimental: Cohort 2; Single subcutaneous administration of PF-06946860 at planned dose level 0.3 mg, or placebo	Biological: PF-06946860; PF-06946860 administered subcutaneously; Other: Placebo; Placebo, administered subcutaneously
Experimental: Cohort 3; Single subcutaneous administration of PF-06946860 at planned dose level 1 mg, or placebo	Biological: PF-06946860; PF-06946860 administered subcutaneously; Other: Placebo; Placebo, administered subcutaneously
Experimental: Cohort 4; Single subcutaneous administration of PF-06946860 at planned dose level 3 mg, or placebo	Biological: PF-06946860; PF-06946860 administered subcutaneously; Other: Placebo; Placebo, administered subcutaneously
Experimental: Cohort 5; Single subcutaneous administration of PF-06946860 at planned dose level 10 mg, or placebo	Biological: PF-06946860; PF-06946860 administered subcutaneously; Other: Placebo; Placebo, administered subcutaneously
Experimental: Cohort 6; Single subcutaneous administration of PF-06946860 at planned dose level 30 mg, or placebo	Biological: PF-06946860; PF-06946860 administered subcutaneously; Other: Placebo; Placebo, administered subcutaneously
Experimental: Cohort 7; Single subcutaneous administration of PF-06946860 at planned dose level 100 mg, or placebo	Biological: PF-06946860; PF-06946860 administered subcutaneously; Other: Placebo; Placebo, administered subcutaneously
Experimental: Optional: Cohort 8; Optional: single subcutaneous administration of PF-06946860 at planned dose level 30 mg, or placebo in healthy Japanese subjects	Biological: PF-06946860; PF-06946860 administered subcutaneously; Other: Placebo; Placebo, administered subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of participants experiencing AE.	Up 9 weeks post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Plasma Decay Half-Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	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

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 30, 2018
• Primary Completion (Actual): September 18, 2019
• Study Completion (Actual): September 18, 2019

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): November 8, 2019
• Last Update Submitted That Met QC Criteria: November 6, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: C3651001; FIH (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