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

Pfizer86 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

PF-06252616BIOLOGICAL

1.0 milligram per kilogram of PF-06252616, IV infusion, single dose

PlaceboDRUG

Placebo for PF-06252616, IV infusion, single dose

PF-06252616BIOLOGICAL

3.0 milligram per kilogram of PF-06252616, IV infusion, single dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Investigational Site

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Incidence of treatment related Adverse Events.

Time frame: Day 197

Severity of treatment related Adverse Events.

Time frame: Day 197

Incidence of abnormal lab findings.

Time frame: Day 197

Magnitude of abnormal lab findings.

Time frame: Day 197

Abnormal and clinically relevant changes in Blood Pressure.

Time frame: Day 197

Abnormal and clinically relevant changes in Pulse Rate.

Time frame: Day 197

Abnormal and clinically relevant changes in Respiratory Rate.

Time frame: Day 197

Abnormal and clinically relevant changes in temperature.

Time frame: Day 197

Abnormal and clinically relevant changes in ECG parameters.

Time frame: Day 197

Secondary Outcomes

PF-06252616 concentration in serum as measured by a validated PK assay for Cmax (maximum concentration)

Time frame: Through Day 197 post dosing

Pharmacodynamic activity as measured by serum concentrations of GDF-8 (myostatin) as measured by a GDF-8 assay

Time frame: Through Day 197 post dosing

Data from ClinicalTrials.gov

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Placebo for PF-06252616, IV infusion, single dose

PF-06252161BIOLOGICAL

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

PlaceboDRUG

Placebo for PF-06252616, IV infusion, single dose

PF-06252616BIOLOGICAL

3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose

PlaceboDRUG

Placebo for PF-06252616, Subcutaneous injection, single dose

PF-06252616BIOLOGICAL

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

PlaceboDRUG

Placebo for PF-06252616, IV infusion, repeat dose

PF-06252616BIOLOGICAL

20.0 milligram per kilogram of PF-06252616, IV infusion, single dose

PlaceboDRUG

Placebo for PF-06252616, IV infusion, single dose

PF-06252616BIOLOGICAL

40.0 milligram per kilogram of PF-06252616, IV infusion, single dose

PlaceboDRUG

Placebo for PF-06252616, IV infusion, single dose

Incidence of development of anti-drug antibody (ADA) as measured by an ADA assay

Time frame: Through Day 197 post dosing

Pharmacologic activity as measured by the percent change in lean body mass as measured by DXA

Time frame: Through Day 113 post dosing

PF-06252616 concentration in serum as measured by a validated PK assay for Tmax (time to reach maximum concentration)

Time frame: Through Day 197 post dosing

PF-06252616 concentration in serum as measured by a validated PK assay for AUCinf (area under the curve serum concentration-time profile from time zero to infinity

Time frame: Through Day 197 post dosing

PF-06252616 concentration in serum as measured by a validated PK assay for AUClast (area under the curve serum concentration from time zero to the time of the last quantifiable concentration)

Time frame: Through Day 197 post dosing

PF-06252616 concentration in serum as measured by a validated PK assay for t1/2 (half-life time for the serum concentration to decrease by half).

Time frame: Through Day 197 post dosing

PF-06252616 concentration in serum as measured by a validated PK assay for AUCτ (area under the curve serum concentration by dose interval)

Time frame: Through Day 197 post dosing

PF-06252616 concentration in serum as measured by a validated PK assay for MRT (mean residence time)

Time frame: Through Day 197 post dosing

PF-06252616 concentration in serum as measured by a validated PK assay for CL (rate of clearance from serum)

Time frame: Through Day 197 post dosing

PF-06252616 concentration in serum as measured by a validated PK assay for CLss (rate of steady state clearance from serum in the repeat dose cohort)

Time frame: Through Day 197 post dosing

PF-06252616 concentration in serum as measured by a validated PK assay for Vz /F(volume of distribution is the theoretical volume which the total amount of drug would need to be uniformly distributed to produce the desired concentration of a drug.)

Time frame: Through Day 197 post dosing

PF-06252616 concentration in serum as measured by a validated PK assay for Vss(volume of distribution is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired concentration of a drug.

Time frame: Through Day 197 post dosing

Steady state volume of distribution is the apparent volume of distribution at steady-state.)

Time frame: Through Day 197 post dosing

PF-06252616 concentration in serum as measured by a validated PK assay for RAC (accumulation ratio for AUC)

Time frame: Through Day 197 post dosing