Trials / Completed
CompletedNCT00435604
A Study of the Subcutaneous Injection of a Viscous Antibody Solution With Recombinant Human Hyaluronidase
Phase I Dose-Ranging Randomized Double-Blinded Controlled Study of the Subcutaneous Injection of a Viscous Antibody Solution With Recombinant Human Hyaluronidase
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- Halozyme Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Hylenex |
Timeline
- Start date
- 2007-02-01
- Completion
- 2007-05-01
- First posted
- 2007-02-15
- Last updated
- 2011-10-17
Source: ClinicalTrials.gov record NCT00435604. Inclusion in this directory is not an endorsement.