NCT07802964尚未招募1 期
A Randomized, Double-blind, Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of a Single Oral Dose of HRS-4139 in Healthy Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Adverse events (AEs)
研究概览
简要总结
This Phase I clinical study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral dose of HRS-4139 in healthy participants.
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)
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
- •Participants who understand the specific procedures of the trial, voluntarily agree to participate in this trial, and provide written informed consent.
- •Participants aged 18 to 55 years (inclusive) at screening.
- •Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) between 18.0 and 26.0 kg/m² (inclusive).
- •Participants who are able to communicate effectively with the investigator, fully understand and comply with all requirements of the trial protocol.
排除标准
- •Participants with any disease of the circulatory, endocrine, neurological, digestive, respiratory, hematologic, immunologic, psychiatric, or metabolic systems, or any other condition that may interfere with the trial results.
- •Participants with a history of malignancy.
- •Participants with a history of risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia), or with short QT syndrome or long QT syndrome, or with a family history in first-degree relatives of unexplained sudden death, drowning, or sudden infant death syndrome (SIDS) occurring at ≤ 40 years of age.
- •Participants who have had an opportunistic infection within 6 months prior to screening; or who have a known history of recurrent or chronic infections, or who have had chronic or recurrent sinusitis, tonsillitis, urinary tract infections, prostatitis, enteritis, etc.
- •Participants who have had an acute infection with systemic symptoms requiring systemic anti-infective therapy (intravenous or oral) within 4 weeks prior to screening.
- •Participants who have participated in any clinical trial of a drug or medical device within 3 months prior to screening, where participation is defined as having signed the informed consent and having received the investigational drug or medical device; or Participants who are still within the follow-up period of any clinical study or within 5 elimination half-lives of the study drug at the time of screening, whichever is longer.
- •Participants who have used any medication (including prescription drugs, over-the-counter medications, Chinese herbal medicines, dietary supplements, etc.) within 2 weeks or within 5 elimination half-lives (whichever is longer) prior to the administration of the study drug; or Participants who plan to use any other medication during the study period.
- •Participants who have received a live (attenuated) vaccine within 1 month prior to screening or plan to receive such a vaccine during the trial period, with the exception of influenza vaccination.
- •Participants who have experienced severe trauma or undergone major surgery within 6 months prior to screening, or who plan to undergo surgery during the trial period.
- •Participants who have donated blood or experienced significant blood loss (≥ 400 mL) within 1 month prior to screening, or who have received a blood transfusion within 2 months prior to screening.
研究组 & 干预措施
HRS-4139 tablet group
Experimental
干预措施: HRS-4139 Tablet (Drug)
HRS-4139 placebo group
Placebo Comparator
干预措施: HRS-4139 Placebo (Drug)
结局指标
主要结局
Adverse events (AEs)
时间窗: Evaluation was performed up to Day 36 or Day 72.
Serious Adverse events (SAEs)
时间窗: Evaluation was performed up to Day 36 or Day 72.
次要结局
- Area under the concentration-time curve from time 0 to infinity (AUC0-inf)(Evaluation was performed up to Day 36 or Day 72.)
- Elimination half-life (t1/2)(Evaluation was performed up to Day 36 or Day 72.)
- Apparent clearance (CL/F)(Evaluation was performed up to Day 36 or Day 72.)
- Apparent volume of distribution (Vd/F)(Evaluation was performed up to Day 36 or Day 72.)
- Incidence and time of onset of Anti drug antibody (ADA) positivity in healthy participants receiving HRS-4139(Evaluation was performed up to Day 36 or Day 72.)
- Plasma concentration of HRS-4139 in healthy participants(Evaluation was performed up to Day 36 or Day 72.)
- Peak concentration (Cmax)(Evaluation was performed up to Day 36 or Day 72.)
- Time to peak concentration (Tmax)(Evaluation was performed up to Day 36 or Day 72.)
- Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC0-last)(Evaluation was performed up to Day 36 or Day 72.)
研究者
研究点 (1)
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