Study Comparing The Tolerability Of Three Excipient Formulations Administered Subcutaneously To Healthy Subjects
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Other: Formulation buffers
- Registration Number
- NCT01401764
- Lead Sponsor
- Ablynx, a Sanofi company
- Brief Summary
The purpose of the study is to compare local pain experienced after subcutaneous injection of three excipient buffers for delivering protein drugs.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Platform II, PASS, ARG 100 Formulation buffers -
- Primary Outcome Measures
Name Time Method Relative perception of pain of platform II versus PASS using a likert scale 2 minute after injections Relative perception of pain of PASS versus Arg 100 using a likert scale 2 minute after injections Perception of pain of Platform II, PASS and Arg 100 using VAS scale. 2 minute after injections Perception of burning of Platform II, PASS and Arg 100 using VAS scale. 2 minute after injections
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Investigational Site
🇧🇪Bruxelles, Belgium