Drug-Drug Interactions of JMKX003142 in Healthy Participants (NCT07565441) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Drug-Drug Interactions of JMKX003142 in Healthy Participants
112 participantsStarted 2026-05-11
Plain-language summary
This is a single-center, non-randomized, open-label, self-controlled, Phase I clinical trial to evaluate the drug-drug interactions (DDI) of JMKX003142 tablets in healthy adult participants.
The study consists of five cohorts (Cohorts 1, 2, 3, 4, and 5). A total of 24 participants are planned enrollment in each of Cohorts 1, 2, 3, and 5, while 16 participants are planned for Cohort 4.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. Participants are able to return to the study center for follow-up as required by the protocol and are willing to comply with study policies, procedures, and restrictions; capable of effective communication with the investigator and completing study-related materials; able to understand the contents of the Informed Consent Form (ICF) and sign the written ICF prior to any study procedures.
✓. Healthy Chinese male or female subjects, as determined by medical history and physical examination. At the time of signing the Informed Consent Form (ICF), aged 18-45 years (inclusive) ; body weight ≥ 50 kg for males or ≥ 45 kg for females; and Body Mass Index (BMI) within the range of 19.0-26.0 kg/m² (inclusive).
✓. Participants were considered healthy by the Investigator based on medical history, baseline physical examination, clinical laboratory assessments, and 12-lead ECG, with all results judged as normal or not clinically significant.
✓. Participants of childbearing potential who agree to use effective contraception and have no plans for conception, cryopreservation, or donation of gametes from ICF signature through 3 months after the last dose.
Exclusion criteria
✕. Known or suspected hypersensitivity to JMKX003142 (active ingredient or excipients), or a history of hypersensitivity to more than two drugs, foods, or other substances.
✕. History or presence of clinically significant diseases in any of the following systems (including but not limited to): cardiovascular, respiratory, gastrointestinal, hematologic, genitourinary, endocrine/metabolic, nervous, psychiatric, musculoskeletal, dermatologic, lymphatic, immune, or sensory organs; or current active local or systemic infection.
✕. Any condition increasing the risk of bleeding, such as acute gastritis, active ulcer with hemorrhage, clinically significant thrombocytopenia or anemia, active pathological bleeding, or a history of intracranial hemorrhage.
What they're measuring
1
Maximum Plasma Concentration (Cmax) of JMKX003142 and its metabolites
Timeframe: for 120 hours
2
Area Under Curve (AUC) of JMKX003142 and its metabolites
Timeframe: for 120 hours
3
Maximum Plasma Concentration (Cmax) of Midazolam and its metabolites
Timeframe: for 144 hours
4
Area Under Curve (AUC) of of Midazolam and its metabolites
Timeframe: for 144 hours
5
Maximum Plasma Concentration (Cmax) of Rosuvastatin
✕. Vital signs meet any of the following criteria at screening: systolic blood pressure ≥ 140 mmHg or \< 90 mmHg; diastolic blood pressure ≥ 90 mmHg or \< 50 mmHg; pulse rate \> 100 bpm or \< 50 bpm; or tympanic temperature ≥ 37.5°C or \< 35°C.
✕. Subjects with a history of QTc interval prolongation or a family history of Long QT Syndrome; or those with clinically significant abnormal ECG findings as determined by the Investigator during screening; or a QTcF ≥ 450 ms; or a QRS interval \> 120 ms.
✕. Positive for Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, Human Immunodeficiency Virus (HIV) antibody, or syphilis serology.
✕. Treatment with therapeutic biological products within 3 months (or 5 half-lives, whichever is longer) prior to dosing, or other prescription/non-prescription medications (including vaccines, Traditional Chinese Medicine \[TCM\], dietary supplements, and health products) within 1 month (or 5 half-lives, whichever is longer).
✕. Use of any investigational drug within 3 months prior to screening, or current participation in another clinical trial.