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Study of a Large Protein Molecule Administered With Escalating Doses of Recombinant Human Hyaluronidase

NCT00369187 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2008-01-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

large protein molecule

Sponsors & Collaborators

  • Halozyme Therapeutics

    lead INDUSTRY

Principal Investigators

  • Malin Prupas, M.D. · Arthritic Center of Reno

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Completion
2006-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00369187 on ClinicalTrials.gov