A First-in-human, Randomized, Single and Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP6590 in Participants With Normal Weight, Overweight and Obesity
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
The goal of this clinical trial is to learn about the safety and tolerability of drug ZP6590 and to learn how the body processes the drug ZP6590 in adults. The main questions it aims to answer are:
- Is the drug ZP6590 safe and well tolerated when administered as escalating single and multiple doses of the ZP6590?
- How quickly and to what extent the administered investigational drug is absorbed and distributed, and how long it takes to be eliminated from the body?
In the first Part of the study:
Participants will:
• Get a single ascending dose of the drug ZP6590 or placebo and will have an observation period of 4 weeks.
In the second Part of the study:
Participants will:
• Get multiple dosages of the drug ZP6590 or placebo for 6 or 12 weeks followed by an observation period of 6 weeks after last dosing.
详细描述
The main objective of this randomized, double-blind, placebo-controlled trial is to assess the safety and tolerability of drug ZP6590 as single ascending doses and multiple ascending doses in healthy participants living with normal weight, overweight and obesity.
In addition, the study will investigate the pharmacokinetics of the drug ZP6590.
The trial is divided in two parts:
SAD-Part 1: Participants will be administered a single subcutaneous dose of the drug ZP6590 or placebo and will have an observation period of 4 weeks.
MAD-Part 2: Participants will be administered multiple dosages of the drug ZP6590 or placebo for 6 or 12 weeks followed by an observation period of 6 weeks after last dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Trial safety group is masked to make decision on dose escalation.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male participant
- •Age between 18 and 55 years, both inclusive
- •Body Mass Index (BMI) between 20.0 and 29.9 kg/m^2, both inclusive
- •Male participant
- •Age between 18 and 60 years, both inclusive
- •Body Mass Index (BMI) between 27.0 and 39.9 kg/m^2, both inclusive
排除标准
- •SAD-Part and MAD-Part:
- •Any clinically significant abnormal haematology, biochemistry, or urinalysis screening tests, as judged by the investigator
- •Treatment for weight management within 3 months before randomization in this trial
研究组 & 干预措施
Drug: ZP6590, solution for injection
ZP6590 will be administered as single dose administration and as multiple dose administrations.
干预措施: ZP6590, solution for injection (Drug)
Placebo, solution for injections
Placebo will be administered as single dose administration and as multiple dose administrations.
干预措施: Placebo, solution for injection (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: Single ascending Dose (SAD)-Part: From Day 1 to Day 29 (4 weeks) Multiple ascending Dose (MAD)-Part: MAD-cohorts (6-Weeks): From Day 1 to Day 78 MAD-cohort (12-Weeks): Day 1 to Day 120
Incidence of treatment emergent adverse events (TEAEs) from first dose to end of trial
次要结局
- To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection(SAD-Part: From Day 1 to Day 29)
- To investigate the pharmacokinetic properties of ZP6590 following single subcutaneous injection(SAD Part: From Day 1 to Day 29)
- To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections(MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dose (12-Weeks Cohort), dosing interval in hours.)
- To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections(MAD-Part: After 1st and 4th doses (6-Weeks and 12-Weeks Cohorts) and after 6th dase (12-Weeks Cohort), dosing interval in hours)
- To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections(MAD-Part: After 2nd, 3rd, 4th, 5th doses (6-Weeks Cohorts and 12-Weeks Cohort) and 6th, 7th, 8th, 9th, 10th, 11th and 12th doses (12-Weeks Cohort))
- To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections(MAD-Part: After 6th (6-Weeks Cohorts) and 12th (12-Weeks-Cohort) doses)
- To investigate the pharmacokinetic properties of ZP6590 following multiple subcutaneous injections(MAD-Part: After 6th (6-Weeks cohorts) and 12th (12-Weeks-Cohort) doses)