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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014