Phase 1 Study for IPG11406 in Health Volunteer

Inclusion Criteria

Participants must meet all of the following criteria to be included in the study:

Demography

• Healthy volunteers aged between 18 and 50 years old, both male and female, are required. Participants must undergo medical history investigation, physical examination, vital signs examination, electrocardiogram, chest X-ray examina-tion, and laboratory tests during the screening period to ensure good health.
• The body mass index (BMI) is between 18 and 32, calculated as: BMI= weight(kg)/ height 2(m 2);
• Participants were required to be in a non-menstrual, non-pregnant, and non-lactating period during the trial and to agree to have no childcare plans for the next 6 months.
• Physical health, defined as: detailed and clear medical history, comprehensive physical examination (including blood pressure and pulse rate, laboratory tests, and 12-lead electrocardiogram) with no clinical abnormalities detected;
• After 10 minutes of supine position testing, vital signs should be within the following range: 95 mmHg <systolic blood pressure (SBP) <140 mmHg 45 mmHg <Diastolic Blood Pressure (DBP) <90 mmHg 45 bpm <Heart Rate (HR) <90 bpm
• After 10 minutes of resting supine position, 12-lead ECG readings: PR interval<120 ms <220 ms, QRS complex <120 ms, QTc (Fridericia recommendedalgorithm) ≤450 ms, normal ECG; or abnormal ECG results deemed clinically insignificant by the investigator.
• Laboratory test results must fall within the normal range (or within the established screening threshold) or show no clinically significant abnormalities; however, serum creatinine, alkaline phosphatase, and liver enzymes (aspartate aminotransferase,Alanine aminotransferase (ALT) should not exceed the upper limit of the laboratory normal range. Total bilirubin should not exceed 1.5 times the upper limit of the normal range for conjugated bilirubin (unless the subject has a history of Gilbert syndrome).
• Willing and able to comply with all treatment, and laboratory testing protocols, agree to take the oral test medication, and meet other study requirements
• Contraceptive requirements for female subjects:
• Fertile female participants: Must undergo a urine pregnancy test during the screening period with a negative result, and agree to use effective contraception for 3 months after signing the informed consent until the last dose of the investigational drug. Contraception must always be strictly followed according to the instructions of the contraceptive product and the investigator. Effective contraception includes: complete abstinence, intra- uterine device (IUD) or intrauterine contraceptive system (IUS), double- barrier method (e.g., spermicide plus male condom, female condom, diaphragm, cervical cap, or intrauterine device), or a partner who has undergone vasectomy and whose semen cannot be detected for sperm. b. Fertile women: This includes postmenopausal women (with complete cessation of menstruation for ≥1 year) or women with surgical records of hysterectomy, bilateral oophorectomy, or bilateral salpingectomy (as opposed to tubal ligation). Fertile women do not need to adhere to the listed contraceptive measures. 10. Contraceptive requirements for male subjects: Male subjects must agree to use the listed effective contraceptive methods or have undergone vasectomy within 3 months after signing the informed consent and receiving the last dose ofthe investigational drug. 11. Participants must provide informed consent for this study prior to enrollment and voluntarily sign a written informed consent form.

Exclusion Criteria

Participants who meet any of the following criteria will be excluded from the study:

Medical history and clinical status

• History of severe cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immune, dermatological, neurological, or psychiat ric disorders. 2. Abnormal chest X-ray findings. 3. Recurrent headache and/or migraine, recurrent nausea and/or vomiting (vomi