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
  Purpose

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


Condition Intervention Phase
Healthy
Other: Formulation buffers
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Ablynx:

Primary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: May 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Platform II, PASS, ARG 100 Other: Formulation buffers
Platform II: Histidine, Polysorbate-80 PASS: Phosphate, Arginine, NaCl ARG 100: Phosphate, 100 mM Arginine

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01401764

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

No publications provided

Responsible Party: Ablynx
ClinicalTrials.gov Identifier: NCT01401764     History of Changes
Other Study ID Numbers: B2271022, 2011-000419-15
Study First Received: July 12, 2011
Last Updated: January 30, 2013
Health Authority: Belgium: Ethics Committee

ClinicalTrials.gov processed this record on April 15, 2014