A First-in-human, Randomized and Double-blind Within Cohorts, Placebo-controlled, Single and Multiple Ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP9830 Administered to Healthy Participants.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Incident of Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
The primary object in this research study is to investigate the safety and tolerability of ZP9830 in healthy study participants, and in addition, the study will investigate how ZP9830 works in the body (pharmacokinetics, PK and pharmacodynamics, PD) compared to placebo.
详细描述
SAD Part A: Participants will receive 1 dose either ZP9830 or placebo as an injection under the skin (subcutaneous, s.c.), and safety and PK will be assessed.
SAD Part B: Participants will receive 1 dose either ZP9830 or placebo as an injection under the skin (subcutaneous, s.c.), and safety, PK and PD will be assessed.
SAD Part C: Participants will receive 1 dose either ZP9830 or placebo as intravenous (i.v.) dose, and safety and PK will be assessed.
MAD Part: Participants will receive multiple doses of either ZP9830 or placebo as an injection under the skin (subcutaneous, s.c.), and safety and PK will be assessed.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participants.
- •18-45 years of age (inclusive).
- •Body weight ≥50 kg.
- •SAD part B only: Fitzpatrick skin type I-III (Caucasian).
- •C-reactive protein ≤10 mg/L.
- •Further inclusion criteria apply.
排除标准
- •Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of it might interfere with, the conduct or the interpretation of the results of the trial, or that would pose an unacceptable risk to the subject in the opinion of the Investigator [following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature) and 12-lead ECG].
- •Any disease associated with immune system impairment, including immune mediated diseases and transplantation patients.
- •Any confirmed significant allergic reactions (urticaria or anaphylaxis) to insect bites.
- •History of neurological disorders including neuropathy, as judged by the investigator.
- •Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug or food (in particular any level of severity of allergy to shellfish), or multiple drug allergies (non-active hay fever is acceptable).
- •Further exclusion criteria apply.
研究组 & 干预措施
ZP9830
Up to 10 SAD cohorts planned:
Part A, 3 cohorts of each 8 participants with 6 participants receiving s.c. active treatment of ZP9830.
Part B, 6 cohorts of each 10 participants with 8 participants receiving s.c. active treatment of ZP9830.
Part C, 1 cohort of 8 participants with 6 participants receiving i.v. active treatment of ZP9830
Up to 4 MAD cohorts planned:
4 cohorts of each 8 participants with 6 participants receiving s.c. active treatment of ZP9830.
干预措施: ZP9830 (Drug)
Placebo
SAD: In each of the 10 single dose cohorts, 2 subjects will receive placebo MAD: In each of the 4 multiple dose cohorts, 2 subjects will receive placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incident of Treatment Emergent Adverse Events (TEAEs)
时间窗: From dosing of ZP9830 (Day 1) to follow-up (SAD: Day 29, MAD: Day 41)
Treatment Emergent Adverse Events (TEAEs) from baseline to follow-up
次要结局
未报告次要终点