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Completed

NCT Number: NCT01689363

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

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

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Key information

Conditions

Allergic Skin Reaction Hypersensitivity Immune System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Amphastar Site 0022, Eugene, Oregon, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyaluronidase

Drug

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

Other names: Amphadase®

Histamine

Drug

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

Other names: Histatrol®

Saline

Drug

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

Primary outcomes

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

    Time frame: 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.

  2. Positive Allergic Reaction to Amphadase® in the Intent-to-Treat Population (ITT)

    Time frame: 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 outcomes

  1. Observed Wheal Size in the Per-Protocol Population (PPP)

    Time frame: 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.

  2. Observed Erythema Size in the Per-Protocol Population (PPP)

    Time frame: 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.

  3. Allergic Wheal Size in the Per-Protocol Population (PPP)

    Time frame: 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.

  4. Allergic Erythema Size in the Per-Protocol Population (PPP)

    Time frame: 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.

  5. Local Itchiness Rate in the Per-Protocol Population (PPP)

    Time frame: 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.

  6. Erythema Responder Rate in the Per-Protocol Population (PPP)

    Time frame: 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.

  7. Observed Wheal Size in the Intent-to-Treat Population (ITT)

    Time frame: 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.

  8. Observed Erythema Size in the Intent-to-Treat Population (ITT)

    Time frame: 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.

  9. Allergic Erythema Size in the Intent-to-Treat Population (ITT)

    Time frame: 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.

  10. Local Itchiness Rate in the Intent-to-Treat Population (ITT)

    Time frame: 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.

  11. Erythema Responder Rate in the Intent-to-Treat Population (ITT)

    Time frame: 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.

  12. Allergic Wheal Size in the Intent-to-Treat Population (ITT)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Amphastar Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Acronym: H001-A2

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Sep 21, 2012
Registry last updated
Jan 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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