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

2014-08-27 03:40:06 | BioPortfolio

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Health Services Research

Conditions

Healthy

Intervention

Hylenex

Status

Completed

Source

Halozyme Therapeutics

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:40:06-0400

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