IPG1094 Phase I Study for China Healthy Participants

Inclusion criteria

• Male and female healthy Chinese participants aged 18 to 50 years (inclusive).
• Comprehensive assessments including physical examination, vital signs, 12-lead ECG, chest X-ray and laboratory tests are normal or with abnormalities judged not clinically significant by the investigator.
• Body weight: Male ≥50.0 kg, Female ≥45.0 kg; Body Mass Index (BMI) ranges from 19.0 to 26.0 (inclusive). BMI = Weight(kg) / Height(m)².
• Female participants are non-pregnant and non-lactating.
• Participants have no pregnancy plan and no sperm/egg donation plan from 2 weeks before screening to 6 months after the end of the study, and agree to use effective contraception during this period.
• Voluntarily sign the written informed consent form, and fully understand the trial content and potential adverse reactions.

Exclusion criteria

• History of severe cardiovascular, respiratory, hepatic, renal, gastrointestinal, neurological, psychiatric or other systemic diseases with clinical significance.
• QTcF interval >450 ms (male) or >470 ms (female).
• History of recurrent headache, nausea or vomiting.
• Blood loss ≥400 mL within 3 months before screening, or plan to donate blood during the study.
• History of orthostatic hypotension or dysphagia.
• History of gastrointestinal diseases affecting drug absorption.
• Lactose intolerance, special dietary restrictions, or unable to follow unified diet requirements during the trial.
• History of drug/food allergy, drug abuse or alcohol abuse.
• Heavy smoking, excessive intake of tea, coffee or caffeinated beverages within 3 months before screening.
• Use of any prescription drugs, over-the-counter drugs, health products or Chinese herbal medicines within 14 days before screening.
• Use of drugs affecting liver metabolism or gastrointestinal environment within 30 days before screening.
• Intake of citrus fruits/juices within 5 days before screening or during the trial.
• Participated in other clinical trials within 3 months before screening.
• Positive result of urine drug screen or breath alcohol test at admission.
• Difficulty in venous blood collection, history of syncope during blood collection.
• Acute illness before screening, or other conditions judged inappropriate for participation by the investigator.