NCT02559258终止1 期
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Escalating Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Epsi- Gam in Healthy, Cat-, Dust Mite-, or Bermuda Grass-Allergic Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Safety and tolerability will be assessed by monitoring AEs (frequency and severity) and SAEs, vital signs, PFTs
研究概览
简要总结
This is a single-center, randomized, double-blind, placebo-controlled, single-dose, dose- escalation study in otherwise healthy cat-, dust mite-, or Bermuda grass-allergic male and female subjects. There will be five dosing cohorts (0.1, 0.3, 1.0, 3.0 and 10.0 mg/kg), with eight subjects in each cohort, randomized to either epsi-gam (6 subjects) or placebo (2 subjects) for a total of 40 subjects. The first cohort will receive the starting dose of 0.1 mg/kg epsi-gam or placebo and subsequent cohorts will be recruited sequentially to receive escalating doses of epsi-gam or placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligible subjects must meet all of the following inclusion criteria:
- •Be informed of the nature of the study and provide written informed consent prior to undergoing screening procedures.
- •Be a healthy male of any race or ethnicity, at least 18 years of age and no more than 65 years of age, inclusively, OR
- •Be a healthy female of any race or ethnicity of non-childbearing potential, at least 18 years of age and no more than 65 years of age, inclusively, OR
- •Be a healthy non-pregnant, non-lactating female of any race or ethnicity of childbearing potential, at least 18 years of age and no more than 65 years of age, inclusive, with a negative pregnancy test who agrees to use 2 medically acceptable forms of birth control from Screening through 57 days after receiving study drug.
- •Have a Body Mass Index (BMI) within the range of 18.5 to 30.0 kg/m
- •Have a history of allergic reactivity to cats, dust mite, or Bermuda grass as expressed by allergic symptoms including rhinitis.
- •Standardized cat allergenic extract (10,000 BAU/mL, ALK- Abello), dust mite allergenic extract (10,000 AU/mL, ALK- Abello), dust mite allergenic extract (10,000 AU/mL, ALK- Abello), or Bermuda grass allergenic extract (10,000 BAU/mL, ALK- Abello) elicits a wheal at least 5 mm up to approximately 10-15 mm in diameter that exceeds two diluent controls by at least 4 mm.
- •Have allergen-specific IgE for cat, dust mite, or Bermuda grass as measured by ImmunoCAP® with a Class rating of 1 or greater.
- •Histamine reactivity of 3 mm or greater, with surrounding erythema, on testing using a standardized epicutaneous delivery device.
- •Be able and willing to discontinue any first and second generation antihistamine use beginning at least 7 days prior to undergoing initial screening skin puncture tests and throughout study participation.
- •Have baseline spirometry (FEV1, FVC, FEF 25%-75%) with FEV1 ≥ 80% predicted and other values within the normal range.
排除标准
- •Subjects who meet any of the following criteria must be excluded:
- •Diluent control elicits a wheal ≥ 3 mm on testing.
- •History of severe systemic allergic reactions to cats, dust mite, or Bermuda grass
- •Clinical history of persistent asthma
- •Dermatographism or any skin disorder (i.e., atopic dermatitis) that would make skin testing or proper interpretation impractical.
- •Chronic urticaria.
- •Underlying heart, liver, kidney, or lung disease or any other medical condition such that the subject would be at increased risk for a poor outcome should a generalized allergic or other reaction occur.
- •Any abnormal laboratory value(s) considered to be clinically significant by the Investigator.
- •Use of systemic corticosteroids within the past three months prior to initial screening.
- •Use of topical corticosteroids on the area(s) to undergo skin tests within the past three weeks prior to initial screening.
- •Use of systemic beta-blocking or ACE-inhibiting agents within the past three weeks prior to initial screening.
- •Use of tricyclic antidepressants within the past three weeks prior to initial screening.
- •Use of H2 antagonists within 24 hours prior to initial screening.
- •Use of any agents known or likely to interact with adrenaline.
- •Use of omalizumab (Xolair®) within the past six months prior to enrolment.
- •Pregnant females as determined by a positive serum or urine hCG test.
- •Lactating females.
- •Participation in another experimental drug or device trial and receipt of an investigational product within the past 30 days, five half-lives or twice the duration of the biochemical effect of the investigational product (whichever is longer) prior to dosing in the present study.
- •Any mental impairment as judged by the Investigator that would limit ability to comply with study requirements.
- •History of infection with, or positive screen for, Hepatitis B (HBsAg, Hepatitis B Surface Antigen), Hepatitis C (HCVAb, Hepatitis C Antibody), or Human Immunodeficiency Virus (HIV 1 or 2).
- •Positive urine screen for drugs of abuse. Positive ethanol breath test.
- •Concurrent disease or condition, that, in the opinion of the Investigator, places the subject at high risk of poor treatment compliance or of not completing the study.
- •Has smoked or consumed nicotine-containing products within past 3 months prior to receiving study drug or has a positive urine test for cotinine, and does not agree to refrain from smoking for the duration of the study.
研究组 & 干预措施
Cohort 2
Experimental
干预措施: 0.3 mg/kg epsi-gam or placebo (6:2) (Drug)
Cohort 4
Experimental
干预措施: 3 mg/kg epsi-gam or placebo (6:2) (Drug)
Cohort 5
Experimental
干预措施: 10 mg/kg epsi-gam or placebo (6:2) (Drug)
Cohort 1
Experimental
干预措施: 0.1 mg/kg epsi-gam or placebo (6:2) (Drug)
Cohort 3
Experimental
干预措施: 1.0 mg/kg epsi-gam or placebo (6:2) (Drug)
结局指标
主要结局
Safety and tolerability will be assessed by monitoring AEs (frequency and severity) and SAEs, vital signs, PFTs
时间窗: From start of study drug administration through Day 57 (+/- 2 days)
ECGs, clinical laboratory values (including clinically significant changes from baseline) from blood and urine samples, performing physical examinations and pregnancy tests and reviewing concomitant medications.
次要结局
未报告次要终点
研究者
研究点 (1)
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