Clinical trial NCT03599063: Singe Dose, First in Human Study of PF- 06946860 in Healthy Adult Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-07-26
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of participants experiencing AE.
timeFrame: Up 9 weeks post dose
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Baseline, up to 9 weeks post dose, as data permit
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: Baseline, up to 9 weeks post dose, as data permit
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Baseline, up to 9 weeks post dose, as data permit
measure: Plasma Decay Half-Life (t1/2)
timeFrame: Baseline, up to 9 weeks post dose, as data permit
measure: Incidence of development of ADA, and if necessary NAb, against PF-06946860
timeFrame: Baseline, up to 9 weeks post-dose, as data permit
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer New Haven Clinical Research Unit
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: