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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Other: Placebo; Biological: PF-06946860

• Registration Number: NCT03974776
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-03
• Study First Submitted QC: 2019-06-03
• Study First Posted: 2019-06-05
• Study Start: 2019-07-08
• Status Verified: 2020-01
• Primary Completion: 2020-01-10
• Study Completion: 2020-01-10
• Last Update Submitted: 2020-01-28
• Last Update Posted: 2020-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Single subcutaneous administration of placebo
PF-06946860	PF-06946860	Single subcutaneous administration of PF-06946860

Primary Outcome Measures

Name	Time	Method
Incidence of participants experiencing AE	Up to 20 weeks post-dose

Secondary Outcome Measures

Name	Time	Method
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	Time measured for the PF-06946860 concentration to decrease by one half.
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

Trial Locations

Locations (1)

Anaheim Clinical Trials LLC-Clinical Research; 🇺🇸 Anaheim, California, United States