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

NCT01689363 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2017-01-20

Study results available
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Summary

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

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.

Sponsors & Collaborators

  • Amphastar Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Selina Su, MPH · A:mphastar Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2012-11-30
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01689363 on ClinicalTrials.gov