NCT07087262招募中1 期
A Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic of SNH-119014 in Healthy Adult Volunteers
ScinnoHub Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2025年6月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Number of Participants With Abnormal Laboratory Values, Clinically Significant Physical Examination Findings, vital signs, electrocardiogram (ECG) and/or Adverse Events/Serious Adverse Events That Are Related to Treatment
研究概览
简要总结
SNH-119014 is an oral small-molecule agonist of pyruvate kinase red blood cell isozyme (PKR) being developed for the treatment of hemolytic anemias. This initial study will characterize the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of a single ascending dose and multiple ascending doses of SNH-119014 in the context of Phase 1 studies in healthy volunteers. The effects of food on the absorption of SNH-119014 will also be evaluated in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 male or female subjects;
- •18-45 years of age, inclusive;
- •Male subjects with body weight ≥50 kg, female subjects with body weight ≥45 kg; BMI ≥18.5 and ≤28.0 kg/m
- •Must provide written informed consent.
排除标准
- •History of or current clinically significant circulatory system, endocrine system, nervous system, digestive system, respiratory system, urinary system, ophthalmology, hematology, immunology, psychiatry disorder, as judged by the investigator；
- •Subjects who have undergone major surgery 6 months prior to screening or who plan to undergo surgery during the study period;
- •Clinically significant abnormal physical examination, vital signs, chest X-ray, laboratory tests during the screening period as judged by the investigator;
- •Subjects with QTcF>450 ms, or with other ECG clinically significant abnormalities during the screening period as judged by the investigator;
- •Subject has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), treponema pallidum antibody, or human immunodeficiency virus (HIV) antibody at screening;
- •Subjects who have a known chronic liver disease, or who have clinically significant abnormal liver function test results during the screening period;
- •History of urinary system diseases.
- •History of dysphagia or any gastrointestinal disorder affecting drug absorption.
- •History of malignancy.
- •History of severe allergies or allergic to the study drug or any of its components. Serious adverse reaction or hypersensitivity to any drug or the formulation excipients.
- •Failure to follow a consistent diet.
- •Over 5 cups (200 ml per cup) of tea, coffee, or caffeinated beverages were consumed daily during the 3 months prior to screening.
- •Consumption of a specific diet (e.g. grapefruit and grapefruit-containing products, chocolate, any food containing caffeine), or vigorous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion within 48 hours before the dose of study drug.
- •Subjects who have taken any drugs that alter the activity of liver enzymes and/or transporters within 28 days prior to screening.
- •Females who are pregnant or lactating and subjects who are unable to use one or more nonpharmacological contraceptives.
- •Subjects who have taken any prescribed or over-the-counter drug or herbal remedies or nutraceutical product within 14 days before the dose of study drug.
- •Subjects who smoked more than 5 cigarettes per day during the 3 months prior to screening, or who cannot accept a smoking ban throughout the study.
- •Alcohol intake >14 units per week within 6 months prior to screening (1 unit is equal to 14g of alcohol such as 360mL of beer, 45mL of 40% spirit, 150mL of wine, or a confirmed positive alcohol breath test, or alcohol prohibition is not acceptable throughout the study.
- •History of drug abuse in the past 1 year prior to screening, or a confirmed positive drugs of abuse test result before randomization.
- •Subjects who plan to conceive or donate sperm or eggs during the study or within 3 months after completion of study.
- •Subjects has received study drug in another clinical study within 3 months before the dose of study drug.
- •Subjects who have donated blood or loss ≥400 mL of blood within 3 months before the dose of study drug, or who plan to donate blood or blood components during the study or within 3 months after completion of study.
- •Subjects who have received a live attenuated vaccine within 28 days before the dose of study drug.
- •Subjects who cannot tolerate venipuncture, or those with a history of needle fainting or blood fainting.
- •In the opinion of the investigator, the subject is not suitable for entry into the study.
研究组 & 干预措施
placebo
Placebo Comparator
干预措施: Placebo (Drug)
SNH-119014
Experimental
干预措施: SNH-119014 (Drug)
结局指标
主要结局
Number of Participants With Abnormal Laboratory Values, Clinically Significant Physical Examination Findings, vital signs, electrocardiogram (ECG) and/or Adverse Events/Serious Adverse Events That Are Related to Treatment
时间窗: up to 7 days or 20 days
Safety and Tolerability
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
1 期
A Study of SC10914 in Patients With Advanced Solid TumorsAdvanced Solid TumorsNCT02940132Jiangxi Qingfeng Pharmaceutical Co. Ltd.72
终止
1 期
A Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SRK-001 in Healthy ParticipantsHealthy ParticipantsNCT05156034Sarkana Pharma Inc16
已完成
1 期
A Study to Evaluate the Safety and Pharmacokinetics of HH-120 Nasal Spray in Healthy VolunteersCOVID-19NCT05753878Huahui Health62
尚未招募
1 期
A Study of HS-10529 in KRAS G12D Patients With Advanced Solid TumorsAdvanced Solid TumorsNCT06963398Jiangsu Hansoh Pharmaceutical Co., Ltd.520
招募中
1 期
Safety and Tolerability Study for T-1301 Capsules to Treat Advanced Solid TumorsAdvanced Solid TumorLymphomaNCT05156203Taivex Therapeutics Corporation30