Clinical trial NCT00435604: A Study of the Subcutaneous Injection of a Viscous Antibody Solution With Recombinant Human Hyaluronidase
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: hyaluronidase
subcutaneous drug delivery
Volunteer Subjects
Lead sponsor: Halozyme Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-02-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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.

Primary outcomes:
measure: The time to inject 20 mL of a viscous antibody solution with and without rHuPH20.
Secondary outcomes:
measure: Assess the time required for a subcutaneous injection with various doses of rHuPH20, safety, tolerability.
Other outcomes:
Locations:
Study officials:
affiliation: Principal Investigator
name: Anoshie Ratnayake, M.D.
role: PRINCIPAL_INVESTIGATOR
References: