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

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. Identifier: NCT00435604
Recruitment Status : Completed
First Posted : February 15, 2007
Last Update Posted : October 17, 2011
Information provided by:
Halozyme Therapeutics

Brief Summary:

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 or disease Intervention/treatment Phase
Healthy Drug: Hylenex Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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
Study Start Date : February 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

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

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

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.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT00435604

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

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Responsible Party: Richard Yocum, M.D., Vice President of Clinical Dev and Med Affairs, Halozyme Therapeutics Identifier: NCT00435604    
Other Study ID Numbers: HZ2-07-01
First Posted: February 15, 2007    Key Record Dates
Last Update Posted: October 17, 2011
Last Verified: February 2007
Keywords provided by Halozyme Therapeutics:
subcutaneous drug delivery
Volunteer Subjects
Additional relevant MeSH terms:
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Immunologic Factors
Physiological Effects of Drugs