NCT01689363

Evaluation of the Allergenicity of AMPHADASE INJECTION (Hyaluronidase Injection USP)

A Randomized, Double-Blinded, Negative- and Positive-Controlled Study for Evaluation of the Allergenicity of Amphadase® in Healthy Volunteers Using Intradermal Skin Test

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 253 (actual)
• Sponsor: Amphastar Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study is designed to evaluate the allergenicity of Amphadase® in healthy volunteers using an intradermal skin test.

Conditions

• Allergic Skin Reaction

Interventions

Type	Name	Description
DRUG	Hyaluronidase	Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two random sites on their forearms.
DRUG	Histamine	Subjects received one intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one random sites on their forearms.
DRUG	Saline	Subjects received one intradermal injection of 0.02 mL saline at one random site on their forearm.

Timeline

• Start date: 2012-09-01
• Primary completion: 2012-11-01
• Completion: 2012-12-01
• First posted: 2012-09-21
• Last updated: 2017-01-20
• Results posted: 2017-01-20

Locations

5 sites across 1 country: United States