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

NCT ID: NCT01616277

Last Updated: 2014-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type PLACEBO_COMPARATOR

PF-06252616

Intervention Type BIOLOGICAL

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

Placebo

Intervention Type DRUG

Placebo for PF-06252616, IV infusion, single dose

2

Group Type PLACEBO_COMPARATOR

PF-06252616

Intervention Type BIOLOGICAL

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

Placebo

Intervention Type DRUG

Placebo for PF-06252616, IV infusion, single dose

3

Group Type PLACEBO_COMPARATOR

PF-06252161

Intervention Type BIOLOGICAL

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

Placebo

Intervention Type DRUG

Placebo for PF-06252616, IV infusion, single dose

4

Group Type PLACEBO_COMPARATOR

PF-06252616

Intervention Type BIOLOGICAL

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

Placebo

Intervention Type DRUG

Placebo for PF-06252616, Subcutaneous injection, single dose

5

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

Group Type PLACEBO_COMPARATOR

PF-06252616

Intervention Type BIOLOGICAL

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

Placebo

Intervention Type DRUG

Placebo for PF-06252616, IV infusion, repeat dose

6

Group Type PLACEBO_COMPARATOR

PF-06252616

Intervention Type BIOLOGICAL

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

Placebo

Intervention Type DRUG

Placebo for PF-06252616, IV infusion, single dose

7

Group Type PLACEBO_COMPARATOR

PF-06252616

Intervention Type BIOLOGICAL

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

Placebo

Intervention Type DRUG

Placebo for PF-06252616, IV infusion, single dose

Interventions

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PF-06252616

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

Intervention Type BIOLOGICAL

Placebo

Placebo for PF-06252616, IV infusion, single dose

Intervention Type DRUG

PF-06252616

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

Intervention Type BIOLOGICAL

Placebo

Placebo for PF-06252616, IV infusion, single dose

Intervention Type DRUG

PF-06252161

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

Intervention Type BIOLOGICAL

Placebo

Placebo for PF-06252616, IV infusion, single dose

Intervention Type DRUG

PF-06252616

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

Intervention Type BIOLOGICAL

Placebo

Placebo for PF-06252616, Subcutaneous injection, single dose

Intervention Type DRUG

PF-06252616

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

Intervention Type BIOLOGICAL

Placebo

Placebo for PF-06252616, IV infusion, repeat dose

Intervention Type DRUG

PF-06252616

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

Intervention Type BIOLOGICAL

Placebo

Placebo for PF-06252616, IV infusion, single dose

Intervention Type DRUG

PF-06252616

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

Intervention Type BIOLOGICAL

Placebo

Placebo for PF-06252616, IV infusion, single dose

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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Wojciechowski J, Purohit VS, Harnisch LO, Dua P, Tan B, Nicholas T. Population PK and PD Analysis of Domagrozumab in Pediatric Patients with Duchenne Muscular Dystrophy. Clin Pharmacol Ther. 2022 Dec;112(6):1291-1302. doi: 10.1002/cpt.2747. Epub 2022 Oct 4.

Reference Type DERIVED
PMID: 36104012 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B5161001&StudyName=A%20Phase%201%20Study%20To%20Evaluate%20The%20Safety%20And%20Tolerability%20Of%20PF-06252616%20In%20Healthy%20Subjects

To obtain contact information for a study center near you, click here.

Other Identifiers

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B5161001

Identifier Type: -

Identifier Source: org_study_id

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