Singe Dose, First in Human Study of PF- 06946860 in Healthy Adult Subjects
Status and phase
Completed
Phase 1
Conditions
Healthy
Treatments
Biological: PF-06946860
Other: Placebo
Details and patient eligibility
About
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.
Enrollment
63 patients
Sex
All
Ages
18 to 55 years old
Volunteers
Accepts Healthy Volunteers
Inclusion and exclusion 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
Trial design
Primary purpose
Basic Science
Allocation
Randomized
Interventional model
Sequential Assignment
Masking
Triple Blind
63 participants in 8 patient groups
Cohort 1
Experimental group
Description:
Single subcutaneous administration of PF-06946860 at planned dose level 0.1 mg, or placebo
Treatment:
Other: Placebo
Biological: PF-06946860
Cohort 2
Experimental group
Description:
Single subcutaneous administration of PF-06946860 at planned dose level 0.3 mg, or placebo
Treatment:
Other: Placebo
Biological: PF-06946860
Cohort 3
Experimental group
Description:
Single subcutaneous administration of PF-06946860 at planned dose level 1 mg, or placebo
Treatment:
Other: Placebo
Biological: PF-06946860
Cohort 4
Experimental group
Description:
Single subcutaneous administration of PF-06946860 at planned dose level 3 mg, or placebo
Treatment:
Other: Placebo
Biological: PF-06946860
Cohort 5
Experimental group
Description:
Single subcutaneous administration of PF-06946860 at planned dose level 10 mg, or placebo
Treatment:
Other: Placebo
Biological: PF-06946860
Cohort 6
Experimental group
Description:
Single subcutaneous administration of PF-06946860 at planned dose level 30 mg, or placebo
Treatment:
Other: Placebo
Biological: PF-06946860
Cohort 7
Experimental group
Description:
Single subcutaneous administration of PF-06946860 at planned dose level 100 mg, or placebo
Treatment:
Other: Placebo
Biological: PF-06946860
Optional: Cohort 8
Experimental group
Description:
Optional: single subcutaneous administration of PF-06946860 at planned dose level 30 mg, or placebo in healthy Japanese subjects
Treatment:
Other: Placebo
Biological: PF-06946860
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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