A Study（Phase I）of GS3-007a Dry Suspension in Healthy Chinese Adults

Inclusion criteria

• Age 18-45 years (inclusive), healthy adult subjects, both male and female are eligible;
• Body Mass Index (BMI): 19-26 kg/m² (inclusive), males weighing ≥50 kg, females weighing ≥45 kg;
• Fully understand the purpose, nature, and methods of the trial, as well as possible adverse reactions, voluntarily participate as subjects, sign the informed consent form (ICF) before any study procedures;
• From screening day to 3 months after the last dose, have no plans for conception or sperm/egg donation, and agree to use reliable non-drug contraception during the trial (such as complete abstinence, intrauterine device, partner sterilization, etc.).

Exclusion criteria

• A highly allergic constitution
• Individuals with a clear history of neurological or psychiatric disorders; those lacking behavioral or cognitive function.
• Electrocardiogram (ECG) QTcF interval abnormal, with a history of QT/QTc interval prolonged; abnormal liver function; abnormal findings in physical examination, laboratory tests, or other examinations with clinical significance.
• Individuals with a history of hepatitis B, hepatitis C, syphilis, AIDS, or with one or more clinically significant abnormal findings in infectious disease screening.
• Individuals who are alcoholics or who regularly consumed alcohol within 6 months before the first dose of the trial, or those unwilling to stop drinking or consuming any alcohol-containing products during the entire trial.
• Individuals with a history of heavy smoking or those who smoked an average of ≥5 cigarettes per day within the 3 months before screening
• Individuals with immune deficiencies or immunosuppressive diseases, malignant tumors, chronic cardiovascular, liver, kidney, endocrine, respiratory, hematological (including coagulation), or digestive system diseases.
• Individuals who underwent major surgery within 6 months before screening or during the screening period, or those who experienced acute neurological, digestive, respiratory, circulatory, endocrine, or hematological diseases within 3 months before screening;
• Subjects who have donated blood (including blood components) within 3 months prior to the first dose, or have experienced blood loss ≥ 400 mL within 3 months prior to the first dose
• Subjects who have participated in any clinical trial and used investigational drugs, vaccines, or devices within 3 months prior to screening
• Subjects who have started a significantly abnormal diet within 4 weeks prior to screening or during the screening period, or have special dietary requirements, cannot comply with the standardized diet, or cannot tolerate the high-fat, high-calorie meal in postprandial trials
• Female subjects who are pregnant or breastfeeding