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

Phase 2

Completed

• Conditions: Allergic Skin Reaction
• Interventions: Drug: Hyaluronidase; Drug: Histamine; Drug: Saline

• Registration Number: NCT01689363
• Lead Sponsor: Amphastar Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-13
• Study First Submitted QC: 2012-09-17
• Study First Posted: 2012-09-21
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Results First Submitted: 2016-07-25
• Status Verified: 2017-01
• Results First Submitted QC: 2017-01-18
• Last Update Submitted: 2017-01-18
• Results First Posted: 2017-01-20
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 253

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm H	Hyaluronidase	Intradermal injection of Amphadase (hyaluronidase 150 USP units/mL)
Arm P	Histamine	Intradermal injection of Histatrol (histamine base 0.1 mg/mL)
Arm N	Saline	Intradermal injection of saline (0.02 mL)

Primary Outcome Measures

Name	Time	Method
Positive Allergic Reaction to Amphadase® in the Per-Protocol Population (PPP)	Up to 30 minutes after the final study drug injection	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.
Positive Allergic Reaction to Amphadase® in the Intent-to-Treat Population (ITT)	Up to 30 minutes after the final study drug injection	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.

Secondary Outcome Measures

Name	Time	Method
Observed Wheal Size in the Per-Protocol Population (PPP)	Up to 30 minutes after the final study drug injection	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. The observed wheal size is the greatest wheal diameter measured at the injection site(s) for a specific study drug injection.
Observed Erythema Size in the Per-Protocol Population (PPP)	Up to 30 minutes after the final study drug injection	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. The observed erythema size is the greatest erythema diameter measured at the injection site(s) for a specific study drug injection.
Allergic Wheal Size in the Per-Protocol Population (PPP)	Up to 30 minutes after the final study drug injection	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. The allergic wheal size is the greatest wheal diameter with accompanying erythema and localized itching measured at the injection site(s) for a specific study drug injection.
Allergic Erythema Size in the Per-Protocol Population (PPP)	Up to 30 minutes after the final study drug injection	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. The allergic erythema size is the greatest erythema diameter with accompanying localized itching measured at the injection site(s) for a specific study drug injection.
Local Itchiness Rate in the Per-Protocol Population (PPP)	Up to 30 minutes after the final study drug injection	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. The local itchiness rate is the percentage of subjects that reported localized itching at the injection site(s) for a specific study drug injection.
Erythema Responder Rate in the Per-Protocol Population (PPP)	Up to 30 minutes after the final study drug injection	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. The erythema responder rate is the percentage of subjects that showed an erythema reaction at the injection site(s) for a specific study drug injection.
Observed Wheal Size in the Intent-to-Treat Population (ITT)	Up to 30 minutes after the final study drug injection	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. The observed wheal size is the greatest wheal diameter measured at the injection site(s) for a specific study drug injection.
Observed Erythema Size in the Intent-to-Treat Population (ITT)	Up to 30 minutes after the final study drug injection	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. The observed erythema size is the greatest erythema diameter measured at the injection site(s) for a specific study drug injection.
Allergic Erythema Size in the Intent-to-Treat Population (ITT)	Up to 30 minutes after the final study drug injection	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. The allergic erythema size is the greatest erythema diameter with accompanying localized itching measured at the injection site(s) for a specific study drug injection.
Local Itchiness Rate in the Intent-to-Treat Population (ITT)	Up to 30 minutes after the final study drug injection	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. The local itchiness rate is the percentage of subjects that reported localized itching at the injection site(s) for a specific study drug injection.
Erythema Responder Rate in the Intent-to-Treat Population (ITT)	Up to 30 minutes after the final study drug injection	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. The erythema responder rate is the percentage of subjects that showed an erythema reaction at the injection site(s) for a specific study drug injection.
Allergic Wheal Size in the Intent-to-Treat Population (ITT)	Up to 30 minutes after the final study drug injection	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. The allergic wheal size is the greatest wheal diameter with accompanying erythema and localized itching measured at the injection site(s) for a specific study drug injection.

Trial Locations

Locations (5)

Amphastar Site 0026; 🇺🇸 Portland, Oregon, United States

Amphastar Site 0038; 🇺🇸 Renton, Washington, United States

Amphastar Site 0022; 🇺🇸 Eugene, Oregon, United States

Amphastar Site 0034; 🇺🇸 Seattle, Washington, United States

Amphastar Site 0023; 🇺🇸 Lake Oswego, Oregon, United States