Healthy
Conditions
Brief summary
The purpose of the study is to compare local pain experienced after subcutaneous injection of three excipient buffers for delivering protein drugs.
Interventions
OTHERFormulation buffers
Platform II: Histidine, Polysorbate-80 PASS: Phosphate, Arginine, NaCl ARG 100: Phosphate, 100 mM Arginine
Sponsors
Ablynx, a Sanofi company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative perception of pain of platform II versus PASS using a likert scale | 0 minute after injections |
| Relative perception of pain of PASS versus Arg 100 using a likert scale | 0 minute after injections |
| Perception of pain of Platform II, PASS and Arg 100 using VAS scale. | 0 minute after injections |
| Perception of burning of Platform II, PASS and Arg 100 using VAS scale. | 0 minute after injections |
Countries
Belgium
Outcome results
None listed