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Completed

NCT Number: NCT01401764

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational Site

Brussels, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Formulation buffers

Other

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

Primary outcomes

  1. Relative perception of pain of platform II versus PASS using a likert scale

    Time frame: 0 minute after injections

  2. Relative perception of pain of platform II versus PASS using a likert scale

    Time frame: 2 minute after injections

  3. Relative perception of pain of PASS versus Arg 100 using a likert scale

    Time frame: 0 minute after injections

  4. Relative perception of pain of PASS versus Arg 100 using a likert scale

    Time frame: 2 minute after injections

  5. Perception of pain of Platform II, PASS and Arg 100 using VAS scale.

    Time frame: 0 minute after injections

  6. Perception of pain of Platform II, PASS and Arg 100 using VAS scale.

    Time frame: 2 minute after injections

  7. Perception of burning of Platform II, PASS and Arg 100 using VAS scale.

    Time frame: 0 minute after injections

  8. Perception of burning of Platform II, PASS and Arg 100 using VAS scale.

    Time frame: 2 minute after injections

Sponsors and collaborators

Lead sponsor

Ablynx, a Sanofi company

Industry

Registry information

Official study title

Randomized, Double Blind, Crossover, Single Centre Study Comparing The Tolerability Of Three Excipient Formulations Administered Subcutaneously To Healthy Subjects

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 25, 2011
Registry last updated
Jan 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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