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

Amphastar Pharmaceuticals, Inc.253 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

TRIPLE

Enrollment

253

Conditions

Allergic Skin Reaction

Interventions

HyaluronidaseDRUG

Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two random sites on their forearms.

HistamineDRUG

Subjects received one intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one random sites on their forearms.

SalineDRUG

Subjects received one intradermal injection of 0.02 mL saline at one random site on their forearm.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Healthy volunteers of either gender; Those without clinically significant cardiovascular gastrointestinal, hepatic, neurological, psychiatric, endocrine, or other major systemic disease that would unduly risk the subject's safety or interfere with the interpretation of results, assessed according to the judgment of the Principal Investigator. A non-inclusive list which would not be exclusionary and define healthy individual for the purposes of this study are: * hypothyroidism, * stable hypertension except those subjects on beta blockers including ocular preparations, * seasonal/perennial allergic rhinitis if able to wash out of antihistamines, * stable, mild intermittent asthma (subjects using beta agonists as a monotherapy on an as-needed basis, excluding daily usage), * migraine if not taking excluded medications, * mild anxiety/depression if not taking excluded medications, and * mild arthritic conditions if not taking excluded medications. * Willingness and ability to sign an informed consent document; * 18 - 80 years of age; * Intact skin at the forearm ; * Female participants are currently practicing effective birth control methods or abstinence. Exclusion Criteria: * Known allergy, hypersensitivity or contraindications to hyaluronidase, thimerosal, edetate disodium (EDTA); * Use of medications within a duration considered to interfere with skin testing. * Known dermographism which may interfere with skin testing. * Pregnant or lactating women.

Locations (5)

Amphastar Site 0022

Eugene, Oregon, United States

Amphastar Site 0023

Lake Oswego, Oregon, United States

Amphastar Site 0026

Portland, Oregon, United States

Amphastar Site 0038

Renton, Washington, United States

Outcomes

Primary Outcomes

Positive Allergic Reaction to Amphadase® in the Per-Protocol Population (PPP)

Subjects received intradermal injections at 4 injection sites following a randomized configuration of study medications. Injection sites were monitored for any characteristic immediate reactions after the study drug injections. A positive reaction consisted of: a) reaction appearing within 30 minutes of drug placement; b) wheal (\>8 mm) with or without pseudopods; c) reaction accompanying erythema; and d) reaction accompanying localized itching.