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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Formulation buffers

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, B-1070
    • Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Relative perception of pain of platform II versus PASS using a likert scale	0 minute after injections
Relative perception of pain of platform II versus PASS using a likert scale	2 minute after injections
Relative perception of pain of PASS versus Arg 100 using a likert scale	0 minute after injections
Relative perception of pain of PASS versus Arg 100 using a likert scale	2 minute after injections
Perception of pain of Platform II, PASS and Arg 100 using VAS scale.	0 minute after injections
Perception of pain of Platform II, PASS and Arg 100 using VAS scale.	2 minute after injections
Perception of burning of Platform II, PASS and Arg 100 using VAS scale.	0 minute after injections
Perception of burning of Platform II, PASS and Arg 100 using VAS scale.	2 minute after injections

Collaborators and Investigators

• Sponsor: Ablynx
• Investigators: Study Director: Josefin-Beate Holz, Ablynx

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: July 12, 2011
• First Submitted That Met QC Criteria: July 22, 2011
• First Posted (Estimate): July 25, 2011

Study Record Updates

• Last Update Posted (Estimate): January 31, 2013
• Last Update Submitted That Met QC Criteria: January 30, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: B2271022; 2011-000419-15