Evaluation of the Allergenicity of AMPHADASE INJECTION (Hyaluronidase Injection USP) (H001-A2)

Amphastar Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Allergic Skin Reaction

Treatments: Drug: Hyaluronidase; Drug: Histamine; Drug: Saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT01689363

API-H001-CLN-A2

Details and patient eligibility

About

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

Enrollment: 253 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

253 participants in 3 patient groups, including a placebo group

Arm H

Experimental group

Description:

Intradermal injection of Amphadase (hyaluronidase 150 USP units/mL)

Treatment:

Drug: Hyaluronidase

Arm P

Active Comparator group

Description:

Intradermal injection of Histatrol (histamine base 0.1 mg/mL)

Treatment:

Drug: Histamine

Arm N

Placebo Comparator group

Description:

Intradermal injection of saline (0.02 mL)

Treatment:

Drug: Saline