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

NCT03974776 | Completed Phase 1 FDA Drug

• 3 other identifiers: C3651002FIPJapanese Ph1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Incidence of participants experiencing AE

  Up to 20 weeks post-dose

Secondary Outcomes (5)

• 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)

  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

Study Arms (2)

PF-06946860

EXPERIMENTAL

Single subcutaneous administration of PF-06946860

Biological: PF-06946860

Placebo

PLACEBO COMPARATOR

Single subcutaneous administration of placebo

Other: Placebo

Interventions

PF-06946860 BIOLOGICAL

PF-06946860 administered subcutaneously

PF-06946860

Placebo OTHER

Placebo administered subcutaneously

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Anaheim Clinical Trials LLC-Clinical Research

Anaheim, California, 92801, United States

Location

Related Links

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 5, 2019
• Study Start: July 8, 2019
• Primary Completion: January 10, 2020
• Study Completion: January 10, 2020
• Last Updated: January 29, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)