A Study of the Subcutaneous Injection of a Viscous Antibody Solution With Recombinant Human Hyaluronidase

This study has been completed.
Sponsor:
Information provided by:
Halozyme Therapeutics
ClinicalTrials.gov Identifier:
NCT00435604
First received: February 14, 2007
Last updated: October 13, 2011
Last verified: February 2007
  Purpose

This Phase I, randomized, double-blinded, within-subject controlled, two-way crossover study comparing the time to inject (flow rate), safety, and tolerability of a subcutaneously (SC) administered, viscous antibody solution of with and without human recombinant hyaluronidase (rHuPH20) in volunteer subjects.

The study hypothesizes that the time required to complete a 20-mL SC injection of a viscous antibody with rHuPH20 will be comparable or shorter than the time required for the injection without rHuPH20.


Condition Intervention Phase
Healthy
Drug: Hylenex
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Health Services Research
Official Title: Phase I Dose-Ranging Randomized Double-Blinded Controlled Study of the Subcutaneous Injection of a Viscous Antibody Solution With Recombinant Human Hyaluronidase

Resource links provided by NLM:


Further study details as provided by Halozyme Therapeutics:

Primary Outcome Measures:
  • The time to inject 20 mL of a viscous antibody solution with and without rHuPH20.

Secondary Outcome Measures:
  • Assess the time required for a subcutaneous injection with various doses of rHuPH20, safety, tolerability.

Estimated Enrollment: 15
Study Start Date: February 2007
Study Completion Date: May 2007
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Volunteers of either sex, age 18 to 65 years, inclusive.
  2. Intact normal skin on both upper extremities without tattoos or potentially obscuring pigmentation or lesions.
  3. Vital signs (BP, HR, temperature, respiratory rate) within normal range.
  4. Metabolic panel (e.g., sodium, potassium, chloride, bicarbonate, BUN, creatinine, glucose, calcium, AST, ALT, alkaline phosphatase, total bilirubin, albumin, and total protein) within normal range within 7 days of injection.
  5. A negative serum or urine pregnancy test (if female of child-bearing potential) within 7 days of injection.
  6. Female subjects of child-bearing potential must be practicing effective birth control or abstinence currently and plan to continue to do so for the duration of the study.
  7. Decision-making capacity and willingness and ability to comply with the requirements for full completion of the trial.
  8. Willingness and ability to sign an informed consent document.

Exclusion Criteria:

  1. Upper extremity edema.
  2. Upper extremity pathology that could interfere with any protocol-specified outcome assessment (e.g., cellulitis, lymphatic disorder or prior surgery, preexisting pain syndrome, previous mastectomy and/or axillary lymph node dissection, etc.).
  3. Contraindication to an antibody, such as known history of anaphylactic or severe systemic reactions.
  4. Known predisposition to renal insufficiency or renal failure, including diabetes mellitus, volume depletion, sepsis, paraproteinemia, and subjects receiving known nephrotoxic drugs.
  5. Known allergy to hyaluronidase or any other ingredient in the formulation of Hylenex.
  6. Known allergy to bee or vespid venom.
  7. Known coagulopathy.
  8. Pregnancy or breast-feeding woman.
  9. Known clinically significant cardiovascular, gastrointestinal, hepatic, neurological, psychiatric, endocrine, cancer, HIV infection, diabetes mellitus, intercurrent illness such as influenza, or other major systemic disease that would unduly risk the subject's safety or interfere with the interpretation of results.
  10. Participation in a study of any investigational drug or device within 30 days of enrollment in this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00435604

Sponsors and Collaborators
Halozyme Therapeutics
Investigators
Principal Investigator: Anoshie Ratnayake, M.D. Principal Investigator
  More Information

No publications provided

Responsible Party: Richard Yocum, M.D., Vice President of Clinical Dev and Med Affairs, Halozyme Therapeutics
ClinicalTrials.gov Identifier: NCT00435604     History of Changes
Other Study ID Numbers: HZ2-07-01
Study First Received: February 14, 2007
Last Updated: October 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Halozyme Therapeutics:
hyaluronidase
subcutaneous drug delivery
Volunteer Subjects

ClinicalTrials.gov processed this record on April 15, 2014