JKN2306 in Healthy Subjects: Single Ascending Dose and Food Effect Study (NCT07412938) | Clinical Trial Compass
CompletedPhase 1
JKN2306 in Healthy Subjects: Single Ascending Dose and Food Effect Study
China44 participantsStarted 2025-02-12
Plain-language summary
This first-in-human, single-center study in China evaluated the safety, tolerability, and pharmacokinetics of single oral doses of JKN2306 tablets in healthy adult subjects and assessed the effect of a high-fat, high-calorie meal on the pharmacokinetics of JKN2306.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion Criteria:
* Healthy Chinese males or females aged 18 to 55 years (inclusive).
* Body weight ≥50 kg for males and ≥45 kg for females; BMI 19.0 to 28.0 kg/m² (inclusive).
* Able and willing to comply with study procedures and restrictions and to complete the study as planned.
* Willing to use medically acceptable contraception and have no plan for pregnancy, sperm donation, or oocyte donation from signing informed consent through 90 days after the last dose.
Exclusion Criteria:
* Participation in another clinical trial within 3 months prior to screening or planned participation during the study.
* Clinically significant diseases or abnormalities that may affect safety or study participation; or conditions that may interfere with absorption, distribution, metabolism, or excretion (e.g., relevant gastrointestinal disorders).
* History of photosensitivity or hypersensitivity/allergy to study drug components, other drugs, or foods.
* Serious infection/major trauma/major surgery within 3 months prior to dosing, or planned surgery during the study; febrile illness or evidence of active infection within 2 weeks prior to first dose.
* Use of medications that may affect hepatic drug metabolism within 28 days; use of prescription/OTC drugs, herbal products, vitamins, or supplements within 14 days prior to dosing or planned use during the study.
* Consumption of grapefruit-related products/caffeine/alcohol and other specified dietary restrictions within 48 hours prior to firs…
What they're measuring
1
Safety and tolerability of single oral doses of JKN2306
Timeframe: SAD: Baseline to Day 8 post-dose.FE: Baseline to Day 15 post-dose.
Trial details
NCT IDNCT07412938
SponsorJoincare Pharmaceutical Group Industry Co., Ltd