NCT01544348已完成1 期
A Phase 1 Randomized, Placebo-controlled, Dose-escalation Study to Evaluate the Safety of MEDI4212 in Subjects With IgE >= 30 IU/mL
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 295
- 试验地点
- 7
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
研究概览
简要总结
Phase 1 study to evaluate the safety of MEDI4212.
详细描述
A Phase 1, randomized, placebo-controlled, dose-escalation study to evaluate the safety and tolerability of ascending single subcutaneous and intravenous doses of MEDI4212 in subjects with immunoglobulin E (IgE) greater than or equal to (>=) 30 international units per milliliters (IU/mL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 through 60 years
- •Written informed consent and any locally required authorization
- •Body weight 45-150 kilogram (kg) for Cohorts 1-3, 4b, and 5-
- •Body weight 45-90 kg for Cohort 4a
- •Females must have been surgically sterilized or postmenopausal
- •Non-sterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Day 1 through Day 85; Both partners to use contraception
- •Sterilized males must be at least 1-year post vasectomy or use a highly effective contraceptive method
- •Healthy Japanese population as determined by a responsible physician
- •Current diagnosis of allergic rhinitis, allergic asthma, or atopic dermatitis (cohorts 1-6) with a diagnostic immunoglobulin E (IgE) of 30 international units per milliliter (IU/mL) at Screening. Diagnostic IgE levels are further restricted for subjects enrolling into each cohort, with the following levels required at Screening: Cohorts 1 and 2: 30-700 IU/mL; Cohort 3: 30-700 IU/mL (4 subjects), greater than (>) 700-1,200 IU/mL (4 subjects), and >1,200 IU/mL (4 subjects); Cohort 4a: 30-500 IU/mL; Cohort 4b: >700 IU/mL; Cohorts 5 and 6: 30-700 IU/mL (4 subjects per cohort) and >700 IU/mL (6 subjects per cohort) or Japanese Cohorts 7-9: greater than or equal to (>=) 30 IU/mL
- •Nonsmoker for >=6 months
- •Obsolete criteria as no longer require Positive in vitro IgE fluorescence enzyme immunoassay (FEIA) response
- •A forced expiration volume in one second (FEV1) >= 80 percent (%) predicted in subjects with asthma. Non-asthmatic subjects with FEV1 >=80% predicted, or with FEV1 less than (<) 80% predicted but who, in the opinion of the investigator, do not have lung disease
- •Ability and willingness to complete the follow-up period through Day 85 as required by the protocol.
排除标准
- •Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
- •Concurrent enrollment in another clinical study
- •Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
- •Exposure to an anti-IgE monoclonal antibodies (MAb) within 12 months prior to Screening
- •Positive drug screen at Screening or Day -
- •A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids, and benzodiazepines
- •History of regular alcohol abuse within 12 months prior to Screening
- •History of sensitivity to any component of the investigational product formulation or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation
- •Subjects with abnormal liver function test values (aspartate transaminase [AST] and alanine transaminase [ALT]) at Screening as defined as follows: a) Liver function test values >= 1.5 times upper limit of normal (ULN)
- •Unwillingness or inability to follow the procedures outlined in the protocol
- •Positive test or history of hepatitis B or positive hepatitis C
- •Positive test or history of human immunodeficiency virus (HIV) or subject is known to be HIV seropositive
- •History of cancer, with the exception of basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success
- •Women who are pregnant, breastfeeding, or lactating
- •Plans to donate blood during the study period
- •Hyper-IgE syndrome or bronchopulmonary aspergillosis
- •Prior history of Immune Complex Disease or type 3 hypersensitivity reactions to MAb administration
- •Known history of prior infusion reaction to MAb administration
- •History of untreated parasitic/helminthic infection within 6 months prior to Screening
- •Uses any of the following medications: a) Oral corticosteroids b) Medium to high dose Immunocorticosteroids (ICS)/ long-acting beta agonists (LABA) c) Immunosuppressives d) Beta blockers
- •If receiving allergy immunotherapy, must be on stable dose for 3 months. Must not receive allergy immunotherapy within 7 days of investigational product administration.
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
时间窗: Day 1 to 85
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to Day 85 that were absent before treatment or that worsened relative to pre-treatment state.
次要结局
- Number of Participants Exhibiting Anti-Drug Antibodies for MEDI4212 at Any Visit(Days 1 (pre-dose), 15, 43, and 85)
- Observed Serum Concentration(Pre-dose and post-dose on Day 1; Day 2, 3, 5, 8, 15, 22, 29, 43, 57 and 85)
- Free Immunoglobulin E (IgE) Serum Concentration(Day -28 (Screening), -1, 1 (pre-dose), 2, 3, 5, 8, 15, 22, 29, 43, 57, and 85 for all groups; 2 hours post-dose on Day 1 for MEDI4212 300 mg Intravenous group only)
研究者
研究点 (7)
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