NCT05096598已完成1 期
A First-in-human, Randomised, Single Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZP8396 Administered to Healthy Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Incidence of treatment emergent adverse events (TEAEs)
研究概览
简要总结
The research study will investigate the safety and tolerability of ZP8396 in healthy study participants. In addition, the study will investigate how ZP8396 works in the body (pharmacokinetics and pharmacodynamics).
Participants will receive 1 single dose either as an injection under the skin (subcutaneous, s.c.) or an injection into a vein of one arm (intravenous, i.v.).
Participants will have 9 visits with the study team. One of these visits consists of 8 overnight stays at the study site. For each participant, the study will last up to 66 days.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subject
- •Body Mass Index (BMI) between 21.0 and 29.9 kg/m^2, both inclusive
- •Body weight of at least 70.0 kg
- •Glycosylated hemoglobin A1c (HbA1c) less than 5.7 percent
- •Further inclusion criteria apply
排除标准
- •History of metabolic diseases more frequently associated with obesity, e.g. type-2-diabetes mellitus, hypertension, dyslipidemia, heart disease or stroke
- •Systolic blood pressure < 90 mmHg or >139 mmHg and/or diastolic blood pressure less than 50 mmHg or greater than 89 mmHg
- •Symptoms of arterial hypotension
- •Further exclusion criteria apply
研究组 & 干预措施
ZP8396
Experimental
Up to 10 single dose cohorts are planned with 8 subjects in each; 6 participants in each cohort will receive active treatment.
干预措施: ZP8396 (Drug)
Placebo (ZP8396)
Placebo Comparator
In each of the 10 single dose cohorts, 2 subjects will receive placebo.
干预措施: Placebo (ZP8396) (Drug)
结局指标
主要结局
Incidence of treatment emergent adverse events (TEAEs)
时间窗: From dosing (Day 1) to end of trial (Day 50)
次要结局
- Pharmacokinetics (PK) of ZP8396 (Cmax)(Day 1 (pre-dose) to Day 50 (1176 hours post-dose))
- Pharmacokinetics (PK) of ZP8396 (tmax)(Day 1 (pre-dose) to Day 50 (1176 hours post-dose))
- Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCacetaminophen, 0-240 min)(0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5)
- Pharmacokinetics (PK) of ZP8396 (CL)(Day 1 (pre-dose) to Day 50 (1176 hours post-dose))
- Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax, Plasma Glucose [PG])(0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5)
- Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax, insulin)(0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5)
- Pharmacokinetics (PK) of ZP8396 (AUCτ)(Day 1 (pre-dose) to Day 50 (1176 hours post-dose))
- Pharmacokinetics (PK) of ZP8396 (Vz)(Day 1 (pre-dose) to Day 50 (1176 hours post-dose))
- Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax, Plasma Glucose [PG])(0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5)
- Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCglucagon,0-60 min)(0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5)
- Pharmacokinetics (PK) of ZP8396 (AUClast)(Day 1 (pre-dose) to Day 50 (1176 hours post-dose))
- Pharmacokinetics (PK) of ZP8396 (Vz/f)(Day 1 (pre-dose) to Day 50 (1176 hours post-dose))
- Pharmacokinetics (PK) of ZP8396 (MRT)(Day 1 (pre-dose) to Day 50 (1176 hours post-dose))
- Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax acetaminophen)(0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5)
- Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCacetaminophen, 0-60 min)(0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5)
- Pharmacokinetics (PK) of ZP8396 (AUCinf)(Day 1 (pre-dose) to Day 50 (1176 hours post-dose))
- Pharmacokinetics (PK) of ZP8396 (λz)(Day 1 (pre-dose) to Day 50 (1176 hours post-dose))
- Pharmacokinetics (PK) of ZP8396 (t½)(Day 1 (pre-dose) to Day 50 (1176 hours post-dose))
- Pharmacokinetics (PK) of ZP8396 (CL/f)(Day 1 (pre-dose) to Day 50 (1176 hours post-dose))
- Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax acetaminophen)(0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5)
- Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCPG,0-60 min)(0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5)
- Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCinsulin,0-60 min)(0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5)
- Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax, glucagon)(0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5)
- Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCPG,0-240 min)(0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5)
- Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Cmax, insulin)(0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5)
- Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCinsulin,0-240 min)(0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5)
- Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (AUCglucagon,0-240 min)(0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5)
- Pharmacodynamics (PD) of ZP8396, for dose cohorts greater than or equal to 0.7 mg (Tmax, glucagon)(0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 and Day 5)
研究者
研究点 (1)
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