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临床试验/NCT05613387
NCT05613387已完成1 期

A Randomized, Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZP8396 Administered to Healthy Subjects

Zealand Pharma1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2022年11月7日最近更新:
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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
68
试验地点
1
主要终点
Incidence of treatment emergent adverse events (TEAEs)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The trial is a single-centre, randomised and double-blind within cohorts, placebo-controlled, sequential multiple ascending dose trial in normal weight and overweight but otherwise healthy subjects randomised to subcutaneous administration of ZP8396 or placebo

详细描述

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).

The trial is divided in two parts:

Part 1: 20 Participants will receive 6 once-weekly doses as an injection under the skin (subcutaneous, s.c.). Participants will have 14 visits with the study team. 6 of these visits consists of overnight stays of different duration (2-4 nights) at the study site. For each participant, the study will last up to 116 days.

Part 2: 48 Participants will receive 16 once-weekly doses as an injection under the skin (subcutaneous, s.c.) in a dose up-titration dose scheme. Participants will have 23 or 24 visits with the study team. 13 of these visits consists of overnight stays of different duration (2-4 nights) at the study site. For each participant, the study will last up to 198 days.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 64 Years（Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Body Mass Index (BMI) between 21.0 and 29.9 kg/m^2, both inclusive
  • •Glycosylated hemoglobin (HbA1c) below 5.7 percent
  • •Further inclusion criteria apply
  • •Body Mass Index (BMI) between 27.0 and 39.9 kg/m^2, both inclusive
  • •Glycosylated hemoglobin (HbA1c) below 6.5 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 below 90 mmHg or above 139 mmHg and/or diastolic blood pressure below 50 mmHg or above 89 mmHg
  • •Symptoms of arterial hypotension
  • •Further exclusion criteria apply
  • •History of metabolic diseases more frequently associated with obesity, e.g. type-2-diabetes mellitus, hypertension, dyslipidemia, heart disease or stroke
  • •Systolic blood pressure below 90 mmHg or above 159 mmHg and/or diastolic blood pressure below 50 mmHg or above 99 mmHg
  • •Symptoms of arterial hypotension
  • •Further exclusion criteria apply

研究组 & 干预措施

ZP8396

Experimental

Part 1: 2 dose cohorts are planned with 10 subjects in each; 7 participants in each cohort will receive active treatment.

Part 2: 3 dose cohorts are planned with 16 subjects in each; 12 participants in each cohort will receive active treatment.

干预措施: ZP8396 (Drug)

结局指标

主要结局

Incidence of treatment emergent adverse events (TEAEs)

时间窗: Part 1: From dosing (Day 1) to end of trial (Day 92); Part 2: From dosing (Day 1) to end of trial (Day 169 for Cohort 1 and 2, Day 176 for Cohort 3)

Incidence of TEAEs from 1st dosing day to end of trial

次要结局

  • Pharmacokinetics (PK) of ZP8396 (AUCinf)(Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3)
  • Pharmacokinetics (PK) of ZP8396 (t½)(Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3)
  • Pharmacokinetics (PK) of ZP8396 (Ctrough)(Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3)
  • Accumulation Ratio for Cmax(Part 1: Day 1 (pre-dose) to Day 92)
  • Pharmacodynamics (PD) of ZP8396 (Cmax acetaminophen)(Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40; Part 2: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1, Day 110 for cohort 1 and 2, Day -1, Day 1, Day 107 for cohort 3)
  • Pharmacodynamics (PD) of ZP8396 (Emax, Plasma Glucose [PG])(Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40; Part 2: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1, Day 110 for cohort 1 and 2, Day -1, Day 1, Day 107 for cohort 3)
  • Pharmacodynamics (PD) of ZP8396 (AUE, Plasma Glucose [PG], 0-60 minutes)(Part 1: 0-60 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40; Part 2: 0-60 minutes, relative to ingestion of MTM/acetaminophen on Day -1, Day 110 for cohort 1 and 2, Day -1, Day 1, Day 107 for cohort 3)
  • Pharmacodynamics (PD) of ZP8396 (AUE, Plasma Glucose [PG], 0-240 minutes)(Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40; Part 2: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1, Day 110 for cohort 1 and 2, Day -1, Day 1, Day 107 for cohort 3)
  • Pharmacodynamics (PD) of ZP8396 (Emax, insulin)(Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40)
  • Pharmacokinetics (PK) of ZP8396 (Cmax)(Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3)
  • Pharmacokinetics (PK) of ZP8396 (tmax)(Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3)
  • Pharmacokinetics (PK) of ZP8396 (Vz/f)(Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3)
  • Accumulation Ratio for AUCτ(Part 1: Day 1 (pre-dose) to Day 92)
  • Pharmacodynamics (PD) of ZP8396 (Tmax acetaminophen)(Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40; Part 2: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1, Day 110 for cohort 1 and 2, Day -1, Day 1, Day 107 for cohort 3)
  • Pharmacodynamics (PD) of ZP8396 (AUEinsulin,0-60 minutes)(Part 1: 0-60 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40)
  • Pharmacokinetics (PK) of ZP8396 (AUClast)(Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3)
  • Pharmacokinetics (PK) of ZP8396 (λz)(Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3)
  • Pharmacokinetics (PK) of ZP8396 (AUCτ)(Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3)
  • Pharmacokinetics (PK) of ZP8396 (CL/f)(Part 1: Day 1 (pre-dose) to Day 92; Part 2: Day 1 (pre-dose) to Day 169 for Cohort 1 and 2, Day 176 for Cohort 3)
  • Pharmacodynamics (PD) of ZP8396 (Tmax, Plasma Glucose [PG])(Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40; Part 2: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1, Day 110 for cohort 1 and 2, Day -1, Day 1, Day 107 for cohort 3)
  • Pharmacodynamics (PD) of ZP8396 (AUCacetaminophen, 0-60 min)(Part 1: 0-60 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40; Part 2: 0-60 minutes, relative to ingestion of MTM/acetaminophen on Day -1, Day 110 for cohort 1 and 2, Day -1, Day 1, Day 107 for cohort 3)
  • Pharmacodynamics (PD) of ZP8396 (AUCacetaminophen, 0-240 min)(Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40; Part 2: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1, Day 110 for cohort 1 and 2, Day -1, Day 1, Day 107 for cohort 3)
  • Pharmacodynamics (PD) of ZP8396 (Tmax, insulin)(Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40)
  • Pharmacodynamics (PD) of ZP8396 (AUEglucagon,0-60 minutes)(Part 1: 0-60 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40)
  • Pharmacodynamics (PD) of ZP8396 (AUEinsulin,0-240 min)(Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40)
  • Pharmacodynamics (PD) of ZP8396 (Emax, glucagon)(Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40)
  • Pharmacodynamics (PD) of ZP8396 (Tmax, glucagon)(Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40)
  • Pharmacodynamics (PD) of ZP8396 (AUEglucagon,0-240 minutes)(Part 1: 0-240 minutes, relative to ingestion of MTM/acetaminophen on Day -1 (baseline), Day 5 and Day 40)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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