A Randomized, Double-Blinded, Negative- and Positive-Controlled Study for Evaluation of the Allergenicity of Amphadase® in Healthy Volunteers Using Intradermal Skin Test
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 253
- 试验地点
- 5
- 主要终点
- Positive Allergic Reaction to Amphadase® in the Per-Protocol Population (PPP)
研究概览
简要总结
This study is designed to evaluate the allergenicity of Amphadase® in healthy volunteers using an intradermal skin test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Arm H
Intradermal injection of Amphadase (hyaluronidase 150 USP units/mL)
干预措施: Hyaluronidase (Drug)
Arm P
Intradermal injection of Histatrol (histamine base 0.1 mg/mL)
干预措施: Histamine (Drug)
Arm N
Intradermal injection of saline (0.02 mL)
干预措施: Saline (Drug)
结局指标
主要结局
Positive Allergic Reaction to Amphadase® in the Per-Protocol Population (PPP)
时间窗: 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)
时间窗: 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.
次要结局
- Observed Wheal Size in the Per-Protocol Population (PPP)(Up to 30 minutes after the final study drug injection)
- Observed Erythema Size in the Per-Protocol Population (PPP)(Up to 30 minutes after the final study drug injection)
- Allergic Wheal Size in the Per-Protocol Population (PPP)(Up to 30 minutes after the final study drug injection)
- Allergic Erythema Size in the Per-Protocol Population (PPP)(Up to 30 minutes after the final study drug injection)
- Local Itchiness Rate in the Per-Protocol Population (PPP)(Up to 30 minutes after the final study drug injection)
- Erythema Responder Rate in the Per-Protocol Population (PPP)(Up to 30 minutes after the final study drug injection)
- Observed Wheal Size in the Intent-to-Treat Population (ITT)(Up to 30 minutes after the final study drug injection)
- Observed Erythema Size in the Intent-to-Treat Population (ITT)(Up to 30 minutes after the final study drug injection)
- Allergic Erythema Size in the Intent-to-Treat Population (ITT)(Up to 30 minutes after the final study drug injection)
- Local Itchiness Rate in the Intent-to-Treat Population (ITT)(Up to 30 minutes after the final study drug injection)
- Erythema Responder Rate in the Intent-to-Treat Population (ITT)(Up to 30 minutes after the final study drug injection)
- Allergic Wheal Size in the Intent-to-Treat Population (ITT)(Up to 30 minutes after the final study drug injection)