Trials / Completed
CompletedNCT00369187
Study of a Large Protein Molecule Administered With Escalating Doses of Recombinant Human Hyaluronidase
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 15 (planned)
- Sponsor
- Halozyme Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This Phase IV, dose escalation, within-patient controlled study of pharmacokinetics (PK), safety and tolerability compares a single dose administration of a large protein molecule without recombinant human hyaluronidase (rHuPH20) to a single dose administration of the large molecule with escalating doses of rHuPH20. The study hypothesizes that an optimal dose of rHuPH20 will increase the bioavailability of large molecule drug administration.
Detailed description
Sequential enrollment into four rHuPH20 dose cohorts.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | large protein molecule |
Timeline
- Start date
- 2006-07-01
- Completion
- 2006-10-01
- First posted
- 2006-08-29
- Last updated
- 2008-01-10
Source: ClinicalTrials.gov record NCT00369187. Inclusion in this directory is not an endorsement.