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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Biological: PF-06946860
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |