NCT05158335已完成1 期
A Phase 1, Randomized, Double Blind, Placebo Controlled, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Single and Multiple Ascending Doses of MBX 2109 in Healthy Participants
MBX Biosciences1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2021年11月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Primary Outcome Measures
研究概览
简要总结
The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of MBX 2109 in healthy volunteers.
This study includes 2 parts. Part A involves a single dose of MBX 2109 taken as a subcutaneous (SC) injection just under the skin. Part B involves repeat doses of MBX 2109 taken as a SC injection just under the skin. Each participant will enroll in only one part.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Double Blind
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women (of nonchildbearing potential) between 20 and 60 years of age, inclusive.
- •Body mass index between 20.0 and 32.0 kg/m2, inclusive.
- •No clinically meaningful findings on physical examination, electrocardiogram, laboratory tests or vital signs
- •Subject has been given signed informed consent
排除标准
- •History of any significant illness or disorder
- •Acute illness within 30 days of administration of first dose of study drug
- •Positive screening result for HIV, hepatitis B or hepatitis C
- •History of or current substance abuse (drug or alcohol) within past 1 year or positive test for drugs of abuse during screening
- •Use of nicotine-containing or vaping products within 3 months prior to screening or check-in
- •Use of cannabis within 45 days prior to check-in
- •Donation of blood within 3 months prior to screening, plasma within 2 weeks prior to screening or platelets within 6 weeks prior to screening
- •Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within past 30 days
研究组 & 干预措施
MBX 2109 (Part A)
Experimental
Single ascending SC doses
干预措施: MBX 2109 (Part A) (Drug)
MBX 2109 (Part B)
Experimental
Repeated ascending SC doses
干预措施: MBX 2109 (Part B) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Primary Outcome Measures
时间窗: Baseline through Day 40 (part A) or Day 60 (Part B)
Number of participants with adverse events (AEs) or Serious Adverse Events (SAEs)
次要结局
- Secondary Outcome Measures 1(Baseline through Day 40 (part A) or Day 60 (Part B))
- Secondary Outcome Measures 2(Baseline through Day 40 (part A) or Day 60 (Part B))
研究者
研究点 (1)
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