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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ablynx
ClinicalTrials.gov Identifier:
NCT01401764
First received: July 12, 2011
Last updated: January 30, 2013
Last verified: January 2013

July 12, 2011
January 30, 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 ] [ Designated as safety issue: No ]
  • Relative perception of pain of platform II versus PASS using a likert scale [ Time Frame: 2 minute after injections ] [ Designated as safety issue: No ]
  • Relative perception of pain of PASS versus Arg 100 using a likert scale [ Time Frame: 0 minute after injections ] [ Designated as safety issue: No ]
  • Relative perception of pain of PASS versus Arg 100 using a likert scale [ Time Frame: 2 minute after injections ] [ Designated as safety issue: No ]
  • Perception of pain of Platform II, PASS and Arg 100 using VAS scale. [ Time Frame: 0 minute after injections ] [ Designated as safety issue: No ]
  • Perception of pain of Platform II, PASS and Arg 100 using VAS scale. [ Time Frame: 2 minute after injections ] [ Designated as safety issue: No ]
  • Perception of burning of Platform II, PASS and Arg 100 using VAS scale. [ Time Frame: 0 minute after injections ] [ Designated as safety issue: No ]
  • Perception of burning of Platform II, PASS and Arg 100 using VAS scale. [ Time Frame: 2 minute after injections ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01401764 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01401764
B2271022, 2011-000419-15
No
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