NCT02870400已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Intravenously and Subcutaneously Administered REGN2477 in Healthy Women Not of Childbearing Potential
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
- 41
- 主要终点
- Treatment emergent adverse events (TEAEs) through day 113 in participants treated with REGN2477
研究概览
简要总结
The primary objective of the study is to assess the safety and tolerability of single ascending doses of REGN2477 in healthy women not of childbearing potential.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women not of childbearing potential between 18 and 65 years of age, with no significant health issues or clinically significant abnormal laboratory findings
- •A body mass index (BMI) between 18 to 30 kg/m2, inclusive
- •Provide a signed informed consent
排除标准
- •Significant illness or history of significant illness
- •Clinically significant abnormal CBC, clinical chemistry, and urine analysis at screening
- •Current smoker or former smoker who has stopped smoking within 3 months prior to screening
- •Positive urine drug test results during screening, or history of drug or alcohol abuse
- •Donation or loss of, blood within 8 weeks prior to screening, or plasma up to 14 days prior to screening
- •History of diabetes
- •Abnormal blood pressure (BP)
- •History of gynecological disorders or malignancies; history of breast malignancies; or history of benign gynecological or breast lesions that require medical treatment or follow up
- •Reduced renal function
- •Known history of chronic hepatitis or HIV
- •Clinically significant ECG abnormalities
- •Participation in any clinical research study within 30 days, or 5 halflives, of the study drug, whichever is greater, or for longer periods per regional requirements, prior to the screening visit
- •Exposure to any biological drugs within 3 months of the screening visit (the name of the drug and duration of previous exposure will be recorded). Vaccination within 4 weeks of screening visit.
- •History of hypersensitivity reactions to vaccines or other biologics
- •History of hypersensitivity to doxycycline or other tetracycline antibiotics
- •History of osteoporosis requiring osteoporosis treatments such as PTH, bisphosphonates, and denosumab
- •Subject using hormone replacement therapy or thyroid replacement therapy will be excluded, unless they have been on stable doses of such therapy for at least 6 months and will remain on the same stable dose through the duration of the trial
- •Use of systemic glucocorticoids, including oral glucocorticoids, for more than 10 days, within 3 months prior to screening.
研究组 & 干预措施
Placebo
Experimental
Cohorts 1 - 5 will receive placebo
干预措施: Placebo (Drug)
REGN2477
Experimental
Cohorts 1 - 5 will receive REGN2477
干预措施: REGN2477 (Drug)
结局指标
主要结局
Treatment emergent adverse events (TEAEs) through day 113 in participants treated with REGN2477
时间窗: Day 1 to Day 113
次要结局
- Immunogenicity of REGN2477, as determined by the presence or absence of Anti-drug antibody (ADA) to REGN2477 over time(Day 1 to Day 113)
- Pharmacokinetic profile of REGN2477, assessed via serum concentrations of REGN2477 over time(Day 1 to Day 113)
研究者
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