A Study to Investigate the Effects of JMKX003142 on QTc Interval in Healthy Adults

Официальное название

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

Обзор

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

Вмешательства

• Препарат JMKX003142 tablets
  Participants will receive single of JMKX003142 6mg
• Препарат JMKX003142 tablets
  Participants will receive single of JMKX003142 30mg
• Препарат Placebo
  Participants will receive single of Placebo

Первичные конечные точки

• The effect of JMKX003142 treatment on placebo-corrected change from baseline QT interval (ΔΔQTc) [Срок оценки: Up to 24 hours post dose]

Вторичные конечные точки (10)

• Placebo-corrected Change From Baseline in Heart Rate After JMKX003142 treatment [Срок оценки: Up to 72 hours post dose]
• Placebo-corrected Change From Baseline in QRS after JMKX003142 treatment [Срок оценки: Up to72 hours post dose]
• Placebo-corrected Change From Baseline in PR Interval After JMKX003142 treatment [Срок оценки: Up to 72 hours post dose]
• Number of Participants With Treatment-emergent Changes in T-wave Morphology and U-wave Presence [Срок оценки: Up to 72 hours post dose]
• Incidence of adverse events to assess the safety of single-dose administration of JMKX003142 [Срок оценки: Up to 72 hours post dose]
• Maximum Observed Plasma Concentration (Cmax) of JMKX003142 [Срок оценки: Up to 72 hours post dose]
• Time to Maximum Observed Plasma Concentration (Tmax) of JMKX003142 [Срок оценки: Up to 72 hours post dose]
• Apparent Terminal Elimination Half-life (T1/2) of JMKX003142 [Срок оценки: 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 [Срок оценки: Up to 72 hours post dose]
• AUC From Time 0 to Infinity (AUCinf) for JMKX003142 [Срок оценки: Up to 72 hours post dose]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07470177 · JMKX003142-104

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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