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Study Comparing The Tolerability Of Three Excipient Formulations Administered Subcutaneously To Healthy Subjects

NCT ID: NCT01401764

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-06-30

Brief Summary

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The purpose of the study is to compare local pain experienced after subcutaneous injection of three excipient buffers for delivering protein drugs.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Platform II, PASS, ARG 100

Group Type OTHER

Formulation buffers

Intervention Type OTHER

Platform II: Histidine, Polysorbate-80 PASS: Phosphate, Arginine, NaCl ARG 100: Phosphate, 100 mM Arginine

Interventions

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Formulation buffers

Platform II: Histidine, Polysorbate-80 PASS: Phosphate, Arginine, NaCl ARG 100: Phosphate, 100 mM Arginine

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy male or female subjects(no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory.
* Body mass index of 17.5 to 30.5 kg/m2; and a total body weight \> 50 kg (110 lbs).

Exclusion Criteria

* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* Acute disease state (e.g., nausea, vomiting, fever, or diarrhea) within 7 days before study day 1.
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

Role: STUDY_DIRECTOR

Ablynx, a Sanofi company

Locations

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Investigational Site

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2011-000419-15

Identifier Type: -

Identifier Source: secondary_id

B2271022

Identifier Type: -

Identifier Source: org_study_id