The main purpose of this study is to evaluate the effect of formulation on relative bioavailability of HDM1002, and the food effect on pharmacokinetics of HDM1002.
According to the medical history, clinical laboratory test results, vital sign measurements, 12 lead ECG results, and physical examination results during the screening period, the investigator considers the subject to be in good general health.
Age range of 18-45 years old (including range), no limit to gender.
Male subject weighed ≥50.0 kg, female subject weighed ≥45.0 kg, and a body mass index (BMI) within the range of 19.0 - 30.0 kg/m2 (including cut-off values).
Female subject of childbearing potentiaafter last dose, who have no childbearing plans and agrl during signature ICF to 30 days after last dose and male subject during signature ICF to 90 days ee to use highly effective contraception and consent not to donate sperm and oocyte during this period.
Subject has a history or family history of medullary thyroid cancer, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2), or calcitonin≥50 ng/L during the screening period.
History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening.
History of acute cholecystitis attack within 3 months prior to screening.
Subject judged by investigator has dysphagia, diseases or conditions that affect gastric emptying, or affect the absorption of gastrointestinal nutrients, such as bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.
Crossover
HDM1002
DrugSingle dose, administered orally. The study is a randomized, open-label, single dose, 3-period, 3 sequence, crossover design.
AUC[0-∞]
Area under the curve from time 0 hour to ∞
AUC[0-t]
Area under the curve from time 0 to t hour
Cmax
Maximum observed concentration
Tmax
Time to maximum plasma concentration
Adverse events (AEs)
Number of subjects reporting AEs
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