NCT07470177尚未招募1 期
A Single-center, Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Effect of a Single-dose of JMKX003142 on QTc Intervals in Healthy Participants
Jemincare0 个研究点目标入组 24 人开始时间: 2026年3月27日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 主要终点
- The effect of JMKX003142 treatment on placebo-corrected change from baseline QT interval (ΔΔQTc)
研究概览
简要总结
The primary objective of this study is to assess the effect of a therapeutic and supratherapeutic oral dose of JMKX003142 on the corrected cardiac QT interval relative to a placebo 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
- Double (Participant, Investigator)
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
- •Participants must be able to return to the study center for follow-up visits as required by the protocol and be willing to comply with study policies, procedures, and constraints. They must be able to communicate effectively with the investigator, complete study-related materials, and understand the contents of the Informed Consent Form (ICF). A written ICF must be signed before any study-specific procedures are performed.
- •Healthy Chinese males or females based on medical history and physical examination. At the time of signing the informed consent form (ICF), participants must be aged 18 to 45 years (inclusive), with a body weight ≥ 50 kg and a body mass index (BMI) between 19.0 and 28.0 $kg/m^2 (inclusive).
- •Participants' health status will be determined by the investigator based on medical history, physical examination, clinical laboratory tests, and 12-lead electrocardiogram (ECG). All test results must be confirmed by the investigator as either normal or abnormal without clinical significance (NCS).
- •Participants of childbearing potential must have no plans to conceive, freeze, or donate sperm/eggs from the time of signing the informed consent form (ICF) until 3 months after the last dose, and must agree to use highly effective contraception methods.
排除标准
- •History or presence of clinically significant diseases, including but not limited to: cardiovascular, respiratory, gastrointestinal, hematological, genitourinary, endocrine and metabolic, neurological, psychiatric, musculoskeletal, dermatological, lymphatic, or immunological systems, or diseases of the sense organs, as well as current systemic or local acute/chronic infections.
- •Participants with any condition that increases the risk of bleeding, such as acute gastritis or active ulcers with bleeding, clinically significant thrombocytopenia or anemia, active pathological bleeding, or a history of intracranial hemorrhage.
- •Vital signs at screening that meet any of the following criteria: systolic blood pressure (SBP) ≥ 140 mmHg or < 90 mmHg; diastolic blood pressure (DBP) ≥ 90 mmHg or < 50 mmHg; pulse rate > 100 bpm or < 50 bpm; or axillary temperature > 37.2°C.
- •History of QTc interval prolongation, or any clinically significant abnormal ECG findings at screening as determined by the investigator, or QTcF ≥ 450 ms, or QRS duration > 120 ms, or PR interval ≥ 200 ms.
- •Clinical laboratory test results at screening showing serum potassium, magnesium, or calcium levels outside the normal range and judged by the investigator to be clinically significant.
研究组 & 干预措施
Part 2
Experimental
干预措施: JMKX003142 tablets (Drug)
Part 2
Experimental
干预措施: Placebo (Drug)
Part 1
Experimental
干预措施: JMKX003142 tablets (Drug)
Part 1
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
The effect of JMKX003142 treatment on placebo-corrected change from baseline QT interval (ΔΔQTc)
时间窗: Up to 24 hours post dose
次要结局
- Placebo-corrected Change From Baseline in Heart Rate After JMKX003142 treatment(Up to 72 hours post dose)
- Placebo-corrected Change From Baseline in QRS after JMKX003142 treatment(Up to72 hours post dose)
- Placebo-corrected Change From Baseline in PR Interval After JMKX003142 treatment(Up to 72 hours post dose)
- Number of Participants With Treatment-emergent Changes in T-wave Morphology and U-wave Presence(Up to 72 hours post dose)
- Incidence of adverse events to assess the safety of single-dose administration of JMKX003142(Up to 72 hours post dose)
- Maximum Observed Plasma Concentration (Cmax) of JMKX003142(Up to 72 hours post dose)
- Time to Maximum Observed Plasma Concentration (Tmax) of JMKX003142(Up to 72 hours post dose)
- Apparent Terminal Elimination Half-life (T1/2) of JMKX003142(Up to 72 hours post dose)
- Area Under the Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUC0-t) for JMKX003142(Up to 72 hours post dose)
- AUC From Time 0 to Infinity (AUCinf) for JMKX003142(Up to 72 hours post dose)
研究者
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