NCT03115996已完成1 期
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously and Subcutaneously Administered Human Monoclonal Antibody REGN3918 in Healthy Volunteers.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Incidence of treatment emergent adverse events (TEAEs)
研究概览
简要总结
To evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses and a multiple dose regimen.
详细描述
Participants will be randomized to single IV or SC or multiple dose treatment with REGN3918 or matched placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blinded
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A subject must meet the follow criteria to be eligible for inclusion in the study:
- •Males and females from 18 to 50 years of age.
- •Subject is judged to be in good health based on medical history, physical examination, vital sign measurements and laboratory safety tests performed at screening and/or prior to administration of initial dose of study drug
- •The subject has a body mass index less than 30 kg/m2
- •Willingness to undergo vaccination and antibiotic prophylaxis against N. meningitides.
排除标准
- •A subject who meets any of the following criteria will be excluded from the study:
- •Any clinically significant physical examination abnormalities observed during the screening visit.
- •Hospitalization for any reason within 30 days of the screening visit
- •Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals.
- •Subject has a history of meningococcal infection.
- •Carriers of Neisseria meningitides based on cultures from naso-pharyngeal swabs during screening.
- •Subject has had a splenectomy.
- •Known allergy to penicillin class antibiotics
- •Known or suspected complement deficiency, or abnormal complement C3, C4 or CH50 during screening.
- •Recent (within the previous 2 months) bacterial, protozoal, viral or parasite infection requiring systemic treatment.
- •History of tuberculosis or systemic fungal diseases
- •HIV infection or HIV seropositivity at the screening visit
- •Positive HBsAg, HBcAb, or hepatitis C antibody at the screening visit
- •History of malignancy (except non-melanoma skin cancer or cervical in-situ)
- •Pregnant or breastfeeding women
- •Women of childbearing potential and men who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
REGN3918 (Cohorts 1-4 & 6a)
Experimental
Cohorts 1-4 and 6a will receive sequential ascending doses of REGN3918
干预措施: REGN3918 (Drug)
Placebo (Cohorts 1-4 & 6a)
Experimental
Cohorts 1-4 and 6a will receive placebo
干预措施: Placebo (Drug)
REGN3918 (Cohort 5 & 6b)
Experimental
Cohort 5 and 6b will receive multiple doses of REGN3918
干预措施: REGN3918 (Drug)
Placebo (Cohort 5 & 6b)
Experimental
Cohort 5 and 6b will receive placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of treatment emergent adverse events (TEAEs)
时间窗: Up to 20 weeks
Severity of TEAEs
时间窗: Up to 20 weeks
次要结局
- Pharmacodynamics profile of REGN3918(Up to 20 weeks)
- Pharmacokinetic profile of REGN3918; single dose IV and SC(Up to 20 weeks)
- Pharmacokinetic profile of REGN3918; single dose IV and repeated SC doses(Up to 20 weeks)
- Pharmacokinetic exploratory analysis(Up to 20 weeks)
- Immunogenicity of REGN3918(Up to 20 weeks)
研究者
研究点 (1)
Loading locations...
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