This is a phase 1, randomised, open-label, three-way, three-period, crossover relative bioavailability study to assess the pharmacokinetics of HRS-6209 capsules (old and new formulation) in healthy participants. The effect of high-fat food on the pharmacokinetics of HRS-6209 in new formulation will also be evaluated. A total of 21 healthy participants will be randomised to receive a single oral dose of HRS-6209 in three treatment periods: old formulation (fasted); new formulation (fasted); new formulation (fasted).
Healthy men and women aged 18 to 50 years old at informed consent signing.
Male body weight ≥ 50 kg, female ≥ 45 kg; BMI 19 to 26 kg/m² at screening and baseline.
Have no clinically significant abnormalities at screening and baseline.
Fertile females and males with fertile female partners: effective contraception 2 weeks before consent, and sustained until 6 months after the last dose (abstinence or highly effective contraception); no sperm/egg donation.
Current or history of clinically significant disorders of any major system (urinary, circulatory, endocrine, nervous, digestive, respiratory, hematologic, immune, psychiatric, metabolic, etc.) or any other condition that may interfere with study results per investigator judgment.
History of epilepsy, including febrile seizures in childhood, loss of consciousness, transient ischemic attack, or any condition predisposing to seizures (e.g., cerebrovascular disease, brain injury, stroke, brain cancer).
Clinically significant acute illness within 1 month prior to screening, including fever or febrile symptoms, viral, bacterial (including upper respiratory tract infection), or non-cutaneous fungal infections.
Any surgery within 6 months prior to study, or planned surgery during study period; prior surgery affecting gastrointestinal absorption (including gastrectomy, bowel resection, bariatric surgery) or affecting liver function.
Crossover
HRS-6209 Capsule (old formulation)
DrugOral administration after fasting.
HRS-6209 Capsule (new formulation)
DrugOral administration after fasting/high-fat meal.
Area under the concentration time curve (AUC)
pharmacokinetics (PK) parameter of HRS-6209.
Maximum Plasma Concentration (Cmax)
pharmacokinetics (PK) parameter of HRS-6209.
Incidence and severity of adverse events / serious adverse events (AEs / SAEs)
Safety assessment, graded as per CTCAE 6.0.
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