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

Phase 1

Completed

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

• Registration Number: NCT03599063
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2018-07-17
• Study First Posted: 2018-07-26
• Study Start: 2018-07-30
• Primary Completion: 2019-09-18
• Study Completion: 2019-09-18
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-06
• Last Update Posted: 2019-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1	Placebo	Single subcutaneous administration of PF-06946860 at planned dose level 0.1 mg, or placebo
Cohort 3	Placebo	Single subcutaneous administration of PF-06946860 at planned dose level 1 mg, or placebo
Cohort 2	PF-06946860	Single subcutaneous administration of PF-06946860 at planned dose level 0.3 mg, or placebo
Cohort 2	Placebo	Single subcutaneous administration of PF-06946860 at planned dose level 0.3 mg, or placebo
Cohort 4	PF-06946860	Single subcutaneous administration of PF-06946860 at planned dose level 3 mg, or placebo
Cohort 4	Placebo	Single subcutaneous administration of PF-06946860 at planned dose level 3 mg, or placebo
Cohort 6	PF-06946860	Single subcutaneous administration of PF-06946860 at planned dose level 30 mg, or placebo
Optional: Cohort 8	Placebo	Optional: single subcutaneous administration of PF-06946860 at planned dose level 30 mg, or placebo in healthy Japanese subjects
Cohort 3	PF-06946860	Single subcutaneous administration of PF-06946860 at planned dose level 1 mg, or placebo
Optional: Cohort 8	PF-06946860	Optional: single subcutaneous administration of PF-06946860 at planned dose level 30 mg, or placebo in healthy Japanese subjects
Cohort 1	PF-06946860	Single subcutaneous administration of PF-06946860 at planned dose level 0.1 mg, or placebo
Cohort 7	Placebo	Single subcutaneous administration of PF-06946860 at planned dose level 100 mg, or placebo
Cohort 5	PF-06946860	Single subcutaneous administration of PF-06946860 at planned dose level 10 mg, or placebo
Cohort 5	Placebo	Single subcutaneous administration of PF-06946860 at planned dose level 10 mg, or placebo
Cohort 6	Placebo	Single subcutaneous administration of PF-06946860 at planned dose level 30 mg, or placebo
Cohort 7	PF-06946860	Single subcutaneous administration of PF-06946860 at planned dose level 100 mg, or placebo

Primary Outcome Measures

Name	Time	Method
Incidence of participants experiencing AE.	Up 9 weeks post dose

Secondary Outcome Measures

Name	Time	Method
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	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Maximum Observed Plasma Concentration (Cmax)	Baseline, up to 9 weeks post dose, as data permit

Trial Locations

Locations (1)

Pfizer New Haven Clinical Research Unit; 🇺🇸 New Haven, Connecticut, United States