NCT06537050Enrolling By Invitation1 期
A Randomized, Double-blind, Placebo-controlled Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of JX2105 in Healthy Chinese Subjects The Purpose of the Study is to Evaluate the Safety, Tolerability After Administration of Single Dose or Multiple Doses, and the Pharmacokinetics (PK) of Single and Multiple Doses of JX2105 in Healthy Study Participants.
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- TEAE/SAE
研究概览
简要总结
The purpose of the study is to evaluate the safety, tolerability after administration of single dose or multiple doses, and the pharmacokinetics (PK) of single and multiple doses of JX2105 in healthy study participants.
详细描述
Overall design:
This study is divided into 3 parts: Part 1: single-dose escalation study (SAD); Part 2: multiple-dose escalation study (MAD); Part 3: food-effect study (FE). Part 1 includes 7 cohorts; Part 2 includes 2~3cohorts; and Part 3 food effect study will conduct on 1 dose strength to evaluate the effect of food intake on pharmacokinetic/pharmacodynamics of JX2105 and its metabolites. The doses of part 2 and 3 will be designed according to the PK parameters from Part 1. Maximum recommended human dose of part 1 is 10 mg and the maximum dose is 180 mg.
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)
盲法说明
Double-Blind
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female healthy participant must be 18 to 75 years of age inclusive.
- •Body mass index (BMI) within the range 18.5 to 28 kg/m^2 (inclusive).
- •Subjects must adhere to contraception restrictions from signing the informed consent to 3 months after the last dose.
- •Willing to participate in the clinical trial and provide signed informed consent.
排除标准
- •Having a history or present condition of diseases or dysfunction that may affect the clinical trial on the consideration of investigator, including but not limited to central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, blood system and other diseases;
- •Having a history or present condition of mental illness;
- •Any surgical condition or condition that could significantly affect the absorption, distribution, metabolism, and excretion of the investigational drug or could jeopardize the subjects participating in the trial; such as a history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcer, gastrointestinal bleeding, etc.;
- •Usage of any drugs within 2 weeks before screening, including prescription drugs, over-the-counter drugs and Chinese herbal medicines;
- •With a known history of allergy to investigational drug ingredients or similar drugs, history of allergic diseases or allergic constitution;
- •Having clinical significance in laboratory test in the opinion of the Investigator, or creatinine clearance < 80 mL/min;
- •Having clinical significant electrocardiogram (ECG) abnormality and chest X-ray examination indicators, in the opinion of the Investigator;
- •Having clinical significance in vital signs, with sitting resting pulse rate < 50 beats/min or > 100 beats/min; systolic blood pressure < 90 mmHg or > 140 mmHg; diastolic blood pressure < 50 mmHg or > 90 mmHg, in the opinion of the Investigator;
- •Having one or more clinically significant tests for hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antibody and treponema pallidum antibody;
- •Female participant with positive pregnancy test results;
- •History of drug or drug abuse within 1 year before screening, or positive urine drug screening;
- •Alcohol abuse within 1 year before screening, with an average weekly alcohol intake of more than 14 units or positive alcohol breath test;
- •With average daily smoking ≥ 5 cigarettes within 3 months before screening;
- •With no suitable veins for multiple venipuncture/catheterization as assessed at screening;
- •Having blood donation (including blood component donation) or massive blood loss (≥ 200 mL) within 3 months before screening; or receive blood transfusion or using blood products;
- •Having a history of surgery within 3 months before screening, or has not recovered from surgery, or will have a scheduled surgery during the study.
研究组 & 干预措施
JX2105
Active Comparator
JX2105 10mg；JX2105 30mg；JX2105 90mg；JX2105 180mg
干预措施: JX2105 (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
TEAE/SAE
时间窗: Day1 to Day 10
The number, frequency and incidence of TEAE/SAE; The number, frequency and incidence of drug-related TEAE/SAE;
次要结局
- CLz/F(Day1 to Day 10)
- Cmax(Day1 to Day 10)
- AUC0-∞(Day1 to Day 10)
- Tmax(Day1 to Day 10)
- t1/2z(Day1 to Day 10)
- λz(Day1 to Day 10)
- Vz/F(Day1 to Day 10)
- MRT0-last、 MRT0-∞(Day1 to Day 10)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Trial of IW-1701 (A Stimulator of Soluble Guanylate Cyclase (sGC)) in Healthy VolunteersHealthyNCT02572349Cyclerion Therapeutics24
已完成
1 期
Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of BIIB033 in Healthy Japanese ParticipantsCentral Nervous System (CNS) Demyelinating DiseaseMultiple SclerosisNCT02641041Biogen24
已完成
1 期
Single Dose Followed by Maintenance Dose Tolerance Study of BIIR 561 CL in Healthy Elderly Male and Female VolunteersHealthyNCT02223507Boehringer Ingelheim13
已完成
1 期
Single Dose of PF-06835919 Escalation Study in Healthy Adult SubjectsNon-alcoholic Fatty Liver DiseaseNCT02974374Pfizer16
已完成
1 期
Study to Evaluate Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GX-E2 in Healthy SubjectsHealthyNCT02291991Genexine, Inc.10