A Randomized, Double-Blinded, Negative- and Positive-Controlled Study for Evaluation of the Allergenicity of Amphadase® in Healthy Volunteers Using Intradermal Skin Test (H001-A2)

NCT01689363 Phase 2 COMPLETED Results posted

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

Details

Lead sponsor	Amphastar Pharmaceuticals, Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	253
Start date	2012-09
Completion	2012-12

Conditions

• Allergic Skin Reaction

Interventions

• Hyaluronidase
• Histamine
• Saline

Primary outcomes

• 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.

Countries

United States