Status:
COMPLETED
Study Comparing The Tolerability Of Three Excipient Formulations Administered Subcutaneously To Healthy Subjects
Lead Sponsor:
Ablynx, a Sanofi company
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to compare local pain experienced after subcutaneous injection of three excipient buffers for delivering protein drugs.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01401764
Start Date
May 1 2011
End Date
June 1 2011
Last Update
January 31 2013
Active Locations (1)
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1
Investigational Site
Brussels, Belgium, B-1070