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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01401764
First Posted: July 25, 2011
Last Update Posted: January 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ablynx
July 12, 2011
July 25, 2011
January 31, 2013
May 2011
June 2011   (Final data collection date for primary outcome measure)
  • Relative perception of pain of platform II versus PASS using a likert scale [ Time Frame: 0 minute after injections ]
  • 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: 0 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: 0 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: 0 minute after injections ]
  • Perception of burning of Platform II, PASS and Arg 100 using VAS scale. [ Time Frame: 2 minute after injections ]
Same as current
Complete list of historical versions of study NCT01401764 on ClinicalTrials.gov Archive Site
Not Provided
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Study Comparing The Tolerability Of Three Excipient Formulations Administered Subcutaneously To Healthy Subjects
Randomized, Double Blind, Crossover, Single Centre Study Comparing The Tolerability Of Three Excipient Formulations Administered Subcutaneously To Healthy Subjects
The purpose of the study is to compare local pain experienced after subcutaneous injection of three excipient buffers for delivering protein drugs.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy
Other: Formulation buffers
Platform II: Histidine, Polysorbate-80 PASS: Phosphate, Arginine, NaCl ARG 100: Phosphate, 100 mM Arginine
Platform II, PASS, ARG 100
Intervention: Other: Formulation buffers
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2011
June 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01401764
B2271022
2011-000419-15
No
Not Provided
Not Provided
Ablynx
Ablynx
Not Provided
Study Director: Josefin-Beate Holz Ablynx
Ablynx
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP