NCT01401764

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started May 2011

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 12, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 25, 2011

Completed
Last Updated

January 31, 2013

Status Verified

January 1, 2013

Enrollment Period

1 month

First QC Date

July 12, 2011

Last Update Submit

January 30, 2013

Conditions

Healthy

Outcome Measures

Primary Outcomes (8)

  • 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

Study Arms (1)

Platform II, PASS, ARG 100

OTHER
Other: Formulation buffers

Interventions

Formulation buffersOTHER

Platform II: Histidine, Polysorbate-80 PASS: Phosphate, Arginine, NaCl ARG 100: Phosphate, 100 mM Arginine

Platform II, PASS, ARG 100

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigational Site

Brussels, B-1070, Belgium

Location

Study Officials

  • Josefin-Beate Holz

    Ablynx, a Sanofi company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2011

First Posted

July 25, 2011

Study Start

May 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

January 31, 2013

Record last verified: 2013-01

Locations

BE(1)