We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
  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: 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

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 ]
  • 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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

Responsible Party: Ablynx
ClinicalTrials.gov Identifier: NCT01401764     History of Changes
Other Study ID Numbers: B2271022
2011-000419-15
First Submitted: July 12, 2011
First Posted: July 25, 2011
Last Update Posted: January 31, 2013
Last Verified: January 2013