NCT01775358已完成1 期
A Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety and Tolerability of ALRN-5281 Administered by Subcutaneous Injection 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
- 33
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
The primary objective of this study is to evaluate the safety and tolerability of a single dose of ALRN-5281 administered by subcutaneous injection to healthy adult volunteers.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects aged 20 to 50 years, inclusive, at the time of informed consent.
- •Subjects must be in good health as determined by the Investigator based on detailed medical history, physical examination, vital signs, clinical laboratory tests, ECGs and other screening evaluations.
- •Ability to provide written informed consent and complying with all study requirements and restrictions.
- •Is a non-smoker and non-tobacco user for a minimum of 6 months prior to screening
排除标准
- •History or current evidence of any clinically significant cardiac, endocrinologic, hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator
- •Previous treatment with any GH Releasing Hormone (GHRH) analog.
- •Participation in another clinical trial or treatment with an investigational agent within 30 days or 5 half-lives, whichever is longer, prior to enrollment.
- •History of cancer within the past five years (excluding non-melanoma skin cancer).
- •History of alcohol or drug abuse or dependence within 12 months of screening as determined by the Investigator.
- •Subjects with a body weight > 120 kg.
研究组 & 干预措施
ALRN-5281 0.015 mg/kg
Experimental
Dosage-0.015 mg/kg
干预措施: ALRN-5281 0.015 mg/kg (Drug)
ALRN-5281 0.05 mg/kg
Experimental
Dosage- 0.05 mg/kg
干预措施: ALRN-5281 0.05 mg/kg (Drug)
ALRN-5281 0.15 mg/kg
Experimental
Dosage- 0.15 mg/kg
干预措施: ALRN-5281 0.15 mg/kg (Drug)
Placebo 0.015 mg/kg
Placebo Comparator
Dosage- 0.015 mg/kg
干预措施: Placebo 0.015 mg/kg (Drug)
Placebo 0.05 mg/kg
Placebo Comparator
Dosage- 0.05 mg/kg
干预措施: Placebo 0.05mg/kg (Drug)
Placebo 0.15 mg/kg
Placebo Comparator
Dosage - 0.15 mg/kg
干预措施: Placebo 0.15mg/kg (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: 28 days
次要结局
- Serum IGF-1(Predose, Day 1-Day 28)
- Serum GH(Predose, Day 1-Day 28)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of ALRN-5281(Predose, Day 1- 0.5,1,2,3,4,6,8,10,12,14 and 16hr post dose , Day 2-Day11 and Day14)
- Maximum plasma concentration (Cmax) of ALRN-5281(Predose, Day 1- 0.5,1,2,3,4,6,8,10,12,14 and 16hr post dose , Day 2-Day11 and Day14)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)](Pre Dose, Day1- 0.5,1,2,3,4,6,8,10,12,14 and 16h post dose, Day2- Day11 and Day 14)
研究者
研究点 (1)
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