NCT03994549已完成早期 1 期
A First in Human, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Dose of ZP7570 in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Safety - Incidence of adverse events (AEs)
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, single ascending dose trial in healthy subjects, randomized to ZP7570 or placebo within each cohort.
详细描述
Sixty-four subjects are planned to be studied in eight cohorts in this first-in human trial. Eight subjects will be allocated to the to eight dose levels. The entire observation period comprise 28 days starting with a 96 hours in-house stay, where discharge is planned for Day 5, followed by five outpatient visits and an End of Trial Visit at Day 28. A blinded evaluation of each cohort will be performed by a Trial Safety Group to determine whether the trial will progress to the next dose level based on the stopping rules specified in protocol.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subject aged between 18 and 55 years, both inclusive.
- •Body Mass Index (BMI) between 18.5 and 28.0 kg/m^2, both inclusive
- •Body weight of at least 60 kg.
- •Heart rate after 5 minutes rest in supine position inside the range of 50-90 beats/min at screening
排除标准
- •Any history of a disorder which in the investigator's opinion might jeopardize subjects safety, evaluation of results or compliance with the protocol.
- •History of gallbladder disease or cholecystectomy.
- •History of major depressive disorder or a Patient Health Questionnaire (PHQ-9) > 9 completed at screening, or a history of other severe psychiatric disorders (e.g. schizophrenia or bipolar disorder).
- •Any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to screening.
- •Clinically significant abnormal standard 12-lead ECG after 5 min resting in supine position at screening, including a QTcF > 450 ms (males) or QTcF > 470 ms (females), PR ≥ 220 ms and QRS ≥ 110 ms as evaluated by the investigator.
- •History of severe hypersensitivity to medicines or foods or history of severe medicinal/food induced anaphylactic reaction or contraindication to the use of Indocyanine Green (e.g. hypersensitivity to iodine).
- •Any clinically significant abnormal hematology, biochemistry, or urinalysis screening tests, as judged by the investigator.
- •TSH values outside of normal reference ranges of safety laboratory
- •Estimated glomerular filtration rate (eGFR) < 90 ml/min/1.73 m2, as defined by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).
- •Known or suspected hypersensitivity to IMP(s) or related products.
- •Systolic blood pressure < 90 mmHg or >139 mmHg and/or diastolic blood pressure < 50 mmHg or > 89 mmHg (one repeat test will be acceptable in case of suspected white-coat hypertension).
- •Symptoms of arterial hypotension
- •Women of childbearing potential who are not using a highly effective contraceptive method
- •Men with non-pregnant partner(s) of childbearing potential not willing to use male contraception (condom) in addition to a highly effective contraceptive method until 28 days after dosing
- •Men with pregnant partner not willing to use male contraception (condom) until 28 days after dosing, in order to avoid exposure of the embryo/fetus to seminal fluid
研究组 & 干预措施
ZP7570
Active Comparator
Single subcutaneous injection
干预措施: Dual GLP-1/GLP-2 Receptor agonists (Drug)
Placebo
Placebo Comparator
Single subcutaneous injection
干预措施: Dual GLP-1/GLP-2 Receptor agonists (Drug)
结局指标
主要结局
Safety - Incidence of adverse events (AEs)
时间窗: From time zero to 28 days after dosing
The incidence, type and severity of adverse events (AEs)
次要结局
- Pharmacokinetics - Area under the plasma concentration-time curve trough(From time zero up to day 28)
- Pharmacokinetics - Area under the plasma concentration-time curve infinity(From time zero up to day 28)
- Pharmacokinetics - Area under the plasma concentration-time curve last(From time zero up to day 28)
- Pharmacokinetics - Maximum plasma concentration(From time zero to 28 days after dosing)
- Pharmacokinetics - Time to maximum plasma concentration (Tmax)(From time zero to 28 days after dosing)
- Pharmacokinetics - Half-life , t½(From time zero to 28 days after dosing)
- Pharmacokinetics - Volume of distribution(From time zero to 28 days after dosing)
- Pharmacokinetics - Mean residence time(From time zero to 28 days after dosing)
- Pharmacokinetics - Body clearance(From time zero to 28 days after dosing)
- Pharmacokinetics - Elimination rate constant(From time zero to 28 days after dosing)
- Pharmacodynamics - Plasma glucose levels(Time Frame: 0-240 minutes)
- Pharmacodynamics - Insulin concentrations(Time Frame: 0-240 minutes)
- Pharmacodynamics - Plasma acetaminophen concentration-time curves(Time Frame: 0-240 minutes)
- Pharmacodynamics - Maximum acetaminophen concentration(Time Frame: 0-240 minutes)
- Pharmacodynamics - Time maximum acetaminophen concentration(Time Frame: 0-240 minutes)
- Safety - Safety lab, haematology(From time zero to 28 days after dosing)
- Safety - Safety lab, clinical chemistry(From time zero to 28 days after dosing)
- Safety - Safety lab, urinalysis(From time zero to 28 days after dosing)
- Safety - Vital signs, blood pressure(From time zero to 28 days after dosing)
- Safety - Vital signs, pulse(From time zero to 28 days after dosing)
- Safety - Physical examination(From time zero to 28 days after dosing)
- Safety - ECG(From time zero to 28 days after dosing)
- Safety - Occurrence of Injection site reactions(From time zero to 28 days after dosing)
- Safety - Immunogenicity: Occurrence of anti-drug antibodies(From time zero to 28 days after dosing)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
First-in-human, Single Ascending Dose Study of CEL383 in Healthy Adult SubjectsHealthyNCT05901883Celsius Therapeutics, Inc.48
已完成
1 期
A Study of PCSK9 Inhibitor AK102 in Healthy SubjectsHypercholesterolaemiaNCT04169386Akeso32
已完成
1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of AMG 890 in Subjects With Elevated Plasma Lipoprotein(a)Cardiovascular DiseaseNCT03626662Amgen79
已完成
1 期
SAD and MAD Study With IV and SC Doses of ARGX-117Healthy VolunteersNCT04532125argenx110
已完成
1 期
A First-time-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of GSK189075A in Healthy Subjects and in Subjects With Type 2 Diabetes MellitusDiabetes Mellitus, Type 2NCT01571661GlaxoSmithKline16