NCT02121080已完成1 期
Study of the Safety and Tolerability of REGN2222(SAR438584) in Healthy Adult 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
- 132
- 主要终点
- The incidence and severity of treatment-emergent adverse events (TEAEs) in participants treated with REGN2222 or placebo.
研究概览
简要总结
This is a phase 1, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetic (PK) profile, and immunogenicity of REGN2222 ascending in cohorts of healthy adult volunteers.
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)
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
- •A healthy man or woman aged 18 to 60 years
- •Body mass index between 18.0 kg/m2 and 32.0 kg/m2, inclusive
- •Willing and able to comply with clinic visits and study-related procedures
- •Provide signed informed consent
排除标准
- •Serum hemoglobin, creatinine, alkaline phosphatase, CPK, and/or hepatic enzymes (aspartate aminotransferase [AST] and alanine aminotransferase [ALT], total bilirubin [unless the investigator has evidence that increased bilirubin corresponds to a Gilbert's type syndrome with elevated indirect bilirubin]) that is >1.5 the upper limit of normal (ULN), or any laboratory findings showing evidence of organ dysfunction or any clinically significant abnormalities from the normal range, as determined by the investigator at the screening visit
- •Use of any concomitant medications within 30 days or at least 5 half-lives, whichever is longer, of the screening visit, including prescription medications (except contraceptives), nutritional supplements, and over-the-counter medications (except acetaminophen)
- •Hospitalization for any reason within 60 days of the screening visit
- •History of or positive human immunodeficiency virus (HIV) screen result at the screening visit
- •History of or positive blood test result for hepatitis B surface antigen and/or hepatitis C virus antibody at the screening visit
- •History of autoimmune disease
- •History of respiratory disease (e.g, asthma, chronic obstructive pulmonary disease)
- •History of drug or alcohol abuse within 1 year prior to the screening visit
- •Participation in any clinical research study evaluating another investigational drug or therapy within 30 days, or within at least 5 half-lives, of the investigational drug (whichever is longer) prior to the screening visit
- •Pregnant or breastfeeding woman
- •Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study, and up to 3 months after the last dose of the study drug (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)
- •Contraception is not required for men with documented vasectomy. **Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of childbearing potential. Contraception is not required for women with documented hysterectomy or tubal ligation.
研究组 & 干预措施
Cohort 1
Experimental
Dosing regimen 1
干预措施: REGN2222(SAR438584) (Drug)
Cohort 1
Experimental
Dosing regimen 1
干预措施: placebo (Drug)
Cohort 2
Experimental
Dosing regimen 2
干预措施: REGN2222(SAR438584) (Drug)
Cohort 2
Experimental
Dosing regimen 2
干预措施: placebo (Drug)
Cohort 3
Experimental
Dosing regimen 3
干预措施: REGN2222(SAR438584) (Drug)
Cohort 3
Experimental
Dosing regimen 3
干预措施: placebo (Drug)
Cohort 4
Experimental
Dosing regimen 4
干预措施: REGN2222(SAR438584) (Drug)
Cohort 4
Experimental
Dosing regimen 4
干预措施: placebo (Drug)
Cohort 5
Experimental
Dosing regimen 5
干预措施: REGN2222(SAR438584) (Drug)
Cohort 5
Experimental
Dosing regimen 5
干预措施: placebo (Drug)
结局指标
主要结局
The incidence and severity of treatment-emergent adverse events (TEAEs) in participants treated with REGN2222 or placebo.
时间窗: from day 1 up to week 20 (EOS)
次要结局
- Serum concentration(from day 1 over time up to week 20)
- Presence or absence of antibodies(from day 1 over time up to week 20)
研究者
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