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

PHASE2CompletedINTERVENTIONAL
Enrollment

253

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

November 30, 2012

Study Completion Date

December 31, 2012

Conditions
Allergic Skin Reaction
Interventions
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.

Trial Locations (5)

97035

Amphastar Site 0023, Lake Oswego

97202

Amphastar Site 0026, Portland

97401

Amphastar Site 0022, Eugene

98057

Amphastar Site 0038, Renton

98115

Amphastar Site 0034, Seattle

All Listed Sponsors
lead

Amphastar Pharmaceuticals, Inc.

INDUSTRY