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

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ClinicalTrials.gov Identifier: NCT01401764
Recruitment Status : Completed
First Posted : July 25, 2011
Last Update Posted : January 31, 2013
Sponsor:
Information provided by (Responsible Party):
Ablynx

Brief Summary:
The purpose of the study is to compare local pain experienced after subcutaneous injection of three excipient buffers for delivering protein drugs.

Condition or disease Intervention/treatment Phase
Healthy Other: Formulation buffers Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Randomized, Double Blind, Crossover, Single Centre Study Comparing The Tolerability Of Three Excipient Formulations Administered Subcutaneously To Healthy Subjects
Study Start Date : May 2011
Primary Completion Date : June 2011
Study Completion Date : June 2011

Arm Intervention/treatment
Platform II, PASS, ARG 100 Other: Formulation buffers
Platform II: Histidine, Polysorbate-80 PASS: Phosphate, Arginine, NaCl ARG 100: Phosphate, 100 mM Arginine



Primary Outcome Measures :
  1. Relative perception of pain of platform II versus PASS using a likert scale [ Time Frame: 0 minute after injections ]
  2. Relative perception of pain of platform II versus PASS using a likert scale [ Time Frame: 2 minute after injections ]
  3. Relative perception of pain of PASS versus Arg 100 using a likert scale [ Time Frame: 0 minute after injections ]
  4. Relative perception of pain of PASS versus Arg 100 using a likert scale [ Time Frame: 2 minute after injections ]
  5. Perception of pain of Platform II, PASS and Arg 100 using VAS scale. [ Time Frame: 0 minute after injections ]
  6. Perception of pain of Platform II, PASS and Arg 100 using VAS scale. [ Time Frame: 2 minute after injections ]
  7. Perception of burning of Platform II, PASS and Arg 100 using VAS scale. [ Time Frame: 0 minute after injections ]
  8. Perception of burning of Platform II, PASS and Arg 100 using VAS scale. [ Time Frame: 2 minute after injections ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01401764


Locations
Belgium
Investigational Site
Bruxelles, Belgium, B-1070
Sponsors and Collaborators
Ablynx
Investigators
Study Director: Josefin-Beate Holz Ablynx

Responsible Party: Ablynx
ClinicalTrials.gov Identifier: NCT01401764     History of Changes
Other Study ID Numbers: B2271022
2011-000419-15
First Posted: July 25, 2011    Key Record Dates
Last Update Posted: January 31, 2013
Last Verified: January 2013