A Phase I Clinical Trial of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of UBT48128 Tablets in Healthy Participants

Inclusion Criteria:

1. Participants must be able to communicate well with the investigator, have fully understood this study, participate voluntarily, understand and comply with all requirements of this study, and sign a written informed consent form before the trial.
2. Aged 18-55 years (inclusive) at the time of signing the informed consent, healthy Chinese males or females.
3. At screening, male body weight > 60 kg and female body weight > 50 kg, with a body mass index (BMI) within 19.0-30.0 kg/m² (inclusive).
4. Body weight change within 3 months prior to screening ≤ 5% (based on self-report).
5. At screening, glycated hemoglobin (HbA1c) < 6.5% and fasting blood glucose < 6.1 mmol/L.
6. Female participants of childbearing potential or male participants must have no plan to reproduce or donate sperm/ova from the time of signing the informed consent form until 3 months after dosing, and must voluntarily adopt the contraceptive measures specified in the study.

Exclusion Criteria:

1. A prior history of, or suspected hypersensitivity or allergic reactions to the investigational product ingredients or other GLP-1 receptor agonist drugs, or being of an allergic constitution (allergic to multiple drugs and foods);
2. Suffering from clinically significant diseases/abnormalities within 1 year prior to screening or currently having clinically significant diseases/abnormalities (including but not limited to diseases of the neuropsychiatric, cardiovascular, respiratory, blood and lymphatic, immune, renal, hepatic, gastrointestinal, metabolic, and skeletal systems);
3. A personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2), or hereditary diseases that predispose to medullary thyroid carcinoma;
4. A history of pancreatitis or concurrent symptomatic pancreatic disease at screening;
5. A history of cholecystitis, or a past history of gallbladder disease that has been symptomatic (except for participants who have previously undergone cholecystectomy and are judged by the investigator as eligible for enrollment);
6. Symptomatic hypoglycemia requiring medical intervention within 12 months prior to screening, or recurrent symptomatic hypoglycemia (≥ 2 episodes) within the past 6 months, or hypoglycemia unawareness;
7. Optic neuropathy at screening, or high-risk factors for non-arteritic anterior ischemic optic neuropathy (NAION) within 6 months prior to screening;