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A Single Dose Study Of The Safety And Investigational Product Level Measurement In Healthy Subjects

NCT ID: NCT01284036

Last Updated: 2013-01-31

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

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-11-30

Brief Summary

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The purpose of this study is to find the safety and side effects of investigational drug in healthy volunteers. See how quickly investigational drug enters the bloodstream, is distributed in the body, broken down and removed in healthy male and female volunteers. See if your body makes antibodies to this investigational drug (how your immune system responds).

Detailed Description

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First in human study to collect safety and pharmacokinetics (PK) of single ascending dose in Healthy subjects

Conditions

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Healthy

Keywords

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Healthy subject safety PK study healthy volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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PF-05230905

9 subjects will participate in each dose cohort. 6 subjects will receive investigational product (PF-05230905) and 3 subjects will receive placebo

Group Type OTHER

PF-05230905

Intervention Type DRUG

Single dose subcutaneous or intravenous (IV) administration of PF-05230905 or placebo

Interventions

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PF-05230905

Single dose subcutaneous or intravenous (IV) administration of PF-05230905 or placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and/or female subjects between the ages of 18 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria

* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
* Receipt or treatment with an investigational or marketed biologic drug.
* blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ablynx, a Sanofi company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Josefin-Beate Holz, MD

Role: STUDY_DIRECTOR

Ablynx, a Sanofi company

Locations

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Investigational Site

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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3294K1-1000

Identifier Type: -

Identifier Source: secondary_id

B2331001

Identifier Type: -

Identifier Source: org_study_id