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A Study To Assess The Safety Of PF-06342674 In Healthy Volunteers

NCT ID: NCT01740609

Last Updated: 2014-06-19

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-06-30

Brief Summary

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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of single escalating doses PF-06342674.

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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. Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

2.0

Group Type EXPERIMENTAL

PF-06342674 Dose A

Intervention Type BIOLOGICAL

Single SC Dose

PF-06342674 Dose B

Intervention Type BIOLOGICAL

Single SC Dose

PF-06342674 Dose C

Intervention Type BIOLOGICAL

Single SC Dose

PF-06342674 Dose D

Intervention Type BIOLOGICAL

Single SC Dose

PF-06342674 Dose E

Intervention Type BIOLOGICAL

Single SC Dose

PF-06342674 Dose F

Intervention Type BIOLOGICAL

Single IV Dose

PF-06342674 Dose G

Intervention Type BIOLOGICAL

Single SC Dose

PF-06342674 Dose H

Intervention Type BIOLOGICAL

Single IV Dose

PF-06342674 Dose I

Intervention Type BIOLOGICAL

Single SC Dose

PF-06342674 Dose J

Intervention Type BIOLOGICAL

Single IV Dose

Interventions

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Placebo

Placebo

Intervention Type DRUG

PF-06342674 Dose A

Single SC Dose

Intervention Type BIOLOGICAL

PF-06342674 Dose B

Single SC Dose

Intervention Type BIOLOGICAL

PF-06342674 Dose C

Single SC Dose

Intervention Type BIOLOGICAL

PF-06342674 Dose D

Single SC Dose

Intervention Type BIOLOGICAL

PF-06342674 Dose E

Single SC Dose

Intervention Type BIOLOGICAL

PF-06342674 Dose F

Single IV Dose

Intervention Type BIOLOGICAL

PF-06342674 Dose G

Single SC Dose

Intervention Type BIOLOGICAL

PF-06342674 Dose H

Single IV Dose

Intervention Type BIOLOGICAL

PF-06342674 Dose I

Single SC Dose

Intervention Type BIOLOGICAL

PF-06342674 Dose J

Single IV Dose

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Male subjects and female of non-childbearing potential subjects between the ages of 18 and 55.
* BMI between 18.5 to 32 kg/m2.
* Total body weight ≥40 kg and ≤120 kg.

Exclusion Criteria

* Previous treatment with an antibody within 6 months prior to Day 1.
* Pregnant or nursing females; females of childbearing potential.
* History of sensitivity to heparin or heparin-induced thrombocytopenia.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 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

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B4351001&StudyName=A%20Study%20To%20Assess%20The%20Safety%20Of%20PF-06342674%20In%20Healthy%20Volunteers

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

Other Identifiers

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B4351001

Identifier Type: -

Identifier Source: org_study_id

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