NCT01401764
Completed
Phase 1
Randomized, Double Blind, Crossover, Single Centre Study Comparing The Tolerability Of Three Excipient Formulations Administered Subcutaneously To Healthy Subjects
Ablynx, a Sanofi company1 site in 1 country30 target enrollmentMay 2011
ConditionsHealthy
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Ablynx, a Sanofi company
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Relative perception of pain of platform II versus PASS using a likert scale
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of the study is to compare local pain experienced after subcutaneous injection of three excipient buffers for delivering protein drugs.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Relative perception of pain of platform II versus PASS using a likert scale
Time Frame: 2 minute after injections
Relative perception of pain of PASS versus Arg 100 using a likert scale
Time Frame: 2 minute after injections
Perception of pain of Platform II, PASS and Arg 100 using VAS scale.
Time Frame: 2 minute after injections
Perception of burning of Platform II, PASS and Arg 100 using VAS scale.
Time Frame: 2 minute after injections
Study Sites (1)
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