A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of NA-931 in Overweight/Obese Participants and in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-Emergent Adverse Events in NA-931 participants
研究概览
简要总结
A randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of NA-931 when administered as single and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with T2DM.
详细描述
A randomized, double-blind, placebo-controlled, dose escalation, first in human study designed to assess the safety and tolerability, pharmacokinetics, and pharmacodynamics of NA-931 when administered as single and multiple-ascending doses in overweight/obese participants and as multiple doses in patients with Type 2 Diabetes Mellitus.
NA-931 is a Quadruple Receptor Agonist for Insulin Like Growth Factor 1 (IGF-1), Glucagon-like Peptide-1 (GLP-1), Gastric Inhibitory Polypeptide (GIP) and Glucagon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants 18-65 years old, inclusive
- •BMI of 25 - 40, inclusive
- •Stable body weight for two months
- •Participants must be capable of giving signed informed consent
- •Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other clinical study procedures
- •Willing to comply with contraception requirements
排除标准
- •History of significant medical conditions and malignancy
- •Uncontrollable hypertension
- •History of alcoholism or drug addiction within 1 year prior to Screening
- •Current or recent participation in an investigational clinical trial
- •Any surgical or medical condition (active or chronic) that may interfere with IP distribution, metabolism, excretion, or drug absorption
研究组 & 干预措施
Participant Group/Arm- NA-931
Experimental: NA-931 Capsule of NA-931 intervention
干预措施: NA-931 (Drug)
Participant Group/Arm- Placebo
Placebo Comparator: Placebo Capsule of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events in NA-931 participants
时间窗: 28 days
To evaluate the safety and tolerability of NA-931
次要结局
- Maximum observe drug concentration (Cmax) of NA-931(28 days)
- Effect of a High-Fat Meal on Plasma Concentration of NA-931(28 days)