NCT07040046招募中1 期
A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and the Food Effect on the Pharmacokinetics of HS-10542 in Healthy Participants
Jiangsu Hansoh Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年5月16日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events (AEs) and the changes in clinical test and examination results
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, dose escalation phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and the food effect on the pharmacokinetics of HS-10542 in healthy participants.
详细描述
This study consists of two parts, of which the Part I consists of the single ascending dose (SAD) study and the food effect (FE) study, while the Part II consists of the multiple ascending dose (MAD) study. The Part I and Part II form this randomized, double-blind, placebo-controlled clinical study to evaluate the safety, tolerability, PK and PD characteristics, as well as the food effect on pharmacokinetics of HS-10542 in Chinese healthy adult participants after single and multiple oral doses.
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
- Double (Participant, Investigator)
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
- 未提供
排除标准
- •Consumed any caffeinated, tea, alcohol, xanthine-rich foods or beverages within 24 hours before administration.
- •Consumed foods known to alter hepatic enzyme activity (eg, pitaya, grapefruit, Seville oranges, etc) and their juice drinks within 1 week before administration.
- •Abnormal vital signs, physical examination, laboratory tests, 12-lead ECG, chest anteroposterior X-ray/CT examination, abdominal ultrasonography, etc. at the time of screening are clinically significant and, as assessed by the investigator, may increase the risk for the participant or affect the interpretation of the study results, which include but are not limited to:
- •Abnormal liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin (TBiL) ≥ 1.5 times ULN.
- •Abnormal renal function: eGFR < 60 mL/min/1.73 m2 at screening or abnormal renal function as judged by the investigator, calculated using the estimation formula of Chronic Kidney Disease Epidemiology Collaboration 2021 (CKD-EPI): eGFR (mL/min/1.73 m2) .
- •Abnormal ECG: The absolute value of QTcF (QT interval corrected by Fridericia 's formula [QT/RR0.33]) > 450 msec for males and > 470 msec for females; or other clinically significant abnormalities as judged by the investigator.
- •Positive hepatitis B virus surface antigen (HBsAg), or negative HBsAg but positive hepatitis B core antibody (HBcAb), or positive HCV Ab, or positive result of any test for HIV antibody or Treponema pallidum-specific antibody at screening and is assessed by the investigator as inappropriate to participate in this trial.
- •participants with inactive, active or latent tuberculosis infection (indicated by tuberculosis on chest X-ray or CT, or positive T-SPOT.TB result) at screening who are assessed as inappropriate for participation in this trial by the investigator.
- •Women with a positive blood pregnancy test result at screening, breastfeeding women, or participants planning to become pregnant during the trial.
- •Used any systemic medication or food (e.g, prescription drugs, over-the-counter drugs, Chinese herbal medicines, health products, special medical supplies, formulas, etc) that could affect the metabolism of investigational drug during the washout period or 5 half-lives (whichever is longer) of a particular drug prior to screening, or participants who are unwilling to undergo washout and discontinue such medication throughout the trial and are assessed as inappropriate for participation in this trial by the investigator. Washout periods for systemic medications or food are detailed in Section 6.
- •Those who have been vaccinated with vaccines other than those specified in this protocol within 1 month before screening or are scheduled to be vaccinated within 1 month after the end of the administration.
- •Those who have participated in a clinical trial involving an intervention with another drug or medical device and received an investigational product or use of a medical device within 1 month prior to screening or within 7 half-lives of the other investigational product, whichever is longer.
- •Those who have donated blood or lost blood ≥ 450 mL within 3 months prior to screening, or planning to donate blood during the trial and at the end or within 3 months of the trial.
- •Those who have a known history of smoking (> 5 cigarettes per day on average) within 3 months prior to screening.
- •Those with diseases or medical conditions that may affect the absorption, distribution, metabolism and excretion of oral drugs within 3 months before screening, such as inflammatory bowel disease, peptic ulcer, gastroesophageal reflux disease, chronic diarrhea, subtotal gastrectomy, etc.
- •Those who have a known history of drug abuse/abuse within 6 months prior to screening, or test positive for drug abuse at screening.
- •Those who have a known history of alcohol dependence (an average of ≥ 14 units of alcohol per week, each unit being equivalent to 285 mL of beer, 125 mL of wine, or 25 mL of liquor) within 6 months prior to screening, or a positive breath alcohol test at screening.
- •Those who have undergone ≥ Grade 2 surgery within 6 months before screening, or plan to have surgery or be hospitalized during the trial.
- •Those who have a previous history of severe drug, food or environmental allergy, or known hypersensitivity to the active substance and excipients of the investigational product (including HS-10542 and placebo).
- •Those with a previous history of capsular microorganisms (e.g., meningococcus or pneumococcus) infection, or those with a history of close contact with individuals infected with meningococcal.
- •Those who have difficulty in swallowing solid preparations such as tablets and capsules.
- •Participants who have difficulty in blood collection, and cannot tolerate multiple venous blood draws or have any contraindications to blood collection.
- •Participants with special dietary requirements or inability to comply with the dietary requirements of the study site.
- •As judged by the investigator, those have a history of or currently have any diseases or conditions that may increase the risk of their participation in the trial, affect their compliance with the protocol, or affect their completion of the trial. These include, but are not limited to, diseases or conditions related to the respiratory, circulatory, digestive, urinary, hematological, endocrine, metabolic, nervous, mental, and immune systems.
研究组 & 干预措施
Cohort1：HS-10542 SAD：HS-10542 capsule
Experimental
干预措施: HS-10542 (Drug)
Cohort2：HS-10542 Placebo SAD：HS-10542 capsule placebo
Placebo Comparator
干预措施: HS-10542 Placebo (Drug)
Cohort3：HS-10542 MAD：HS-10542 capsule
Experimental
干预措施: HS-10542 (Drug)
Cohort4：HS-10542 Placebo MAD：HS-10542 capsule placebo
Placebo Comparator
干预措施: HS-10542 Placebo (Drug)
结局指标
主要结局
Incidence and severity of adverse events (AEs) and the changes in clinical test and examination results
时间窗: From screening to day 11 or day 21.
The incidence and severity of adverse events (AEs), serious adverse events (SAEs), and adverse events leading to withdrawal from the study, as well as their correlation with the investigational drug.And the changes in clinical test and examination results before and after administration
次要结局
- PK parameters: Apparent volume of distribution at steady state (Vss/F)(up to 240 hours after dosing)
- Pharmacokinetics (PK) parameters：Observed maximum plasma concentration（Cmax）(up to 240 hours after dosing)
- Pharmacokinetics (PK) parameters：Time to reach maximum plasma concentration(Tmax）(up to 240 hours after dosing)
- Pharmacokinetics (PK) parameters：area under the concentration-time curve from time 0 to time t of last measurable concentration( AUC0-t)(up to 240 hours after dosing)
- PK parameters: Maximum plasma concentration at steady state (Css, max)(up to 240 hours after dosing)
- PK parameters: time to Css, max (Tss, max)(up to 240 hours after dosing)
- PK parameters: Minimum plasma concentration at steady state (Css, min)(up to 240 hours after dosing)
- PK parameters: Area under the plasma concentration-time curve over a dosing interval at steady state (AUCss)(up to 240 hours after dosing)
- PK parameters: Apparent clearance at steady state (CLss/F)(up to 240 hours after dosing)
- PK parameters: Degree of accumulation after multiple doses (Rac)(up to 240 hours after dosing)
- PK parameters: Elimination half-life (t½)(up to 240 hours after dosing)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Phase I Study of GZR18 Injection in Obese/Overweight SubjectsOverweight and ObesityNCT06548945Gan and Lee Pharmaceuticals, USA16
已完成
1 期
A Dose-escalation Study of LPM3480392 in Chinese Healthy SubjectsHealthyNCT05862974Luye Pharma Group Ltd.80
已完成
1 期
Study of Safety, Tolerability, and Pharmacokinetics of REGN3470-3471-3479 in Healthy Adult VolunteersHealthy VolunteersNCT02777151Regeneron Pharmaceuticals24
已完成
1 期
A Study to Evaluate the Safety and Efficacy of DDO-3055 in Healthy Volunteers and Patients With Chronic Kidney DiseaseChronic Kidney DiseaseNCT03976115Jiangsu HengRui Medicine Co., Ltd.54
Unknown
1 期
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of DA-8010 in Healthy SubjectsOveractive BladderNCT02821312Dong-A ST Co., Ltd.110