A Phase 1 Study To Evaluate The Safety And Tolerability Of PF-06252616 In Healthy Subjects

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: PF-06252616; Drug: Placebo; Biological: PF-06252161

Study type: Interventional

Funder types: Industry

Identifiers

NCT01616277

B5161001

Details and patient eligibility

About

The purpose of this study is to determine if the study drug, PF-06252616 is safe and well tolerated when given to adult healthy volunteers.

Enrollment: 86 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Single Dose Cohorts-Healthy male and/or female non-child bearing subjects between the ages of 18 and 55 years, inclusive.
• Repeat Dose Cohort-Healthy male and/or female non-child bearing subjects between the ages of 18 and less than 65 years, inclusive.

Exclusion criteria

• Presence or history of muscle disease (eg, polymyositis or rhabdomyolysis).
• Weight loss or gain of >5% within 30 days of Screening, as reported by subject.
• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, immunologic, metabolic urologic, dermatologic, renal, allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) and any other major disease.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 7 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Biological: PF-06252616

Drug: Placebo

Drug: Placebo

Biological: PF-06252616

Drug: Placebo

Drug: Placebo

Biological: PF-06252616

Drug: Placebo

Biological: PF-06252616

Drug: Placebo

Drug: Placebo

Biological: PF-06252616

Biological: PF-06252616

2

Placebo Comparator group

Treatment:

Biological: PF-06252616

Drug: Placebo

Drug: Placebo

Biological: PF-06252616

Drug: Placebo

Drug: Placebo

Biological: PF-06252616

Drug: Placebo

Biological: PF-06252616

Drug: Placebo

Drug: Placebo

Biological: PF-06252616

Biological: PF-06252616

3

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Biological: PF-06252161

Drug: Placebo

Drug: Placebo

4

Placebo Comparator group

Treatment:

Biological: PF-06252616

Drug: Placebo

Drug: Placebo

Biological: PF-06252616

Drug: Placebo

Drug: Placebo

Biological: PF-06252616

Drug: Placebo

Biological: PF-06252616

Drug: Placebo

Drug: Placebo

Biological: PF-06252616

Biological: PF-06252616

5

Placebo Comparator group

Description:

Repeat dose of PF-06252616, IV infusion, single dose - 10.0 miligram per kilogram

Treatment:

Biological: PF-06252616

Drug: Placebo

Drug: Placebo

Biological: PF-06252616

Drug: Placebo

Drug: Placebo

Biological: PF-06252616

Drug: Placebo

Biological: PF-06252616

Drug: Placebo

Drug: Placebo

Biological: PF-06252616

Biological: PF-06252616

6

Placebo Comparator group

Treatment:

Biological: PF-06252616

Drug: Placebo

Drug: Placebo

Biological: PF-06252616

Drug: Placebo

Drug: Placebo

Biological: PF-06252616

Drug: Placebo

Biological: PF-06252616

Drug: Placebo

Drug: Placebo

Biological: PF-06252616

Biological: PF-06252616

7

Placebo Comparator group

Treatment:

Biological: PF-06252616

Drug: Placebo

Drug: Placebo

Biological: PF-06252616

Drug: Placebo

Drug: Placebo

Biological: PF-06252616

Drug: Placebo

Biological: PF-06252616

Drug: Placebo

Drug: Placebo

Biological: PF-06252616

Biological: PF-06252616