A Clinical Trial of TQH3906 Capsules in Healthy Volunteers

Inclusion Criteria:

• Healthy subjects aged 18-55 years (including 18 and 55 years), regardless of gender.

• Males weighing ≥ 50 kg, females weighing ≥ 45 kg, with a body mass index (BMI) of 19-26 kg/m2 (included).

• Be in good health with no abnormalities of clinical significance according tomedical history, clinical symptoms, vital signs, physical examination, 12-leadelectrocardiogram, chest radiographs, abdominal ultrasound, and laboratory tests

• Have a full understanding of the study, participate in the trial voluntarily, andhave signed a written informed consent form.

• Subjects (including partners) are willing to voluntarily use appropriate andeffective contraception from screening until 3 months after the last dose of studydrug.

Exclusion Criteria:

• Pregnant, lactating women.

• Previous history or current cardiac, endocrine, metabolic, renal, hepatic,gastrointestinal, dermatologic, infectious, hematologic, neurologic, or psychiatricdisorders/abnormalities, or related chronic illnesses, or acute illnesses, which theinvestigator assesses as contraindicated for participation in the trial.

• Have a QTc > 450 ms in males and > 470 ms in females at screening, or whoseElectrocardiograph (ECG) is unsuitable for Concentration QT (C-QT) measurement (atthe discretion of the investigator).

• The presence of risk factors and history of tip-twist ventricular tachycardiaincluding, but not limited to: unexplained syncope, long QT syndrome, heart failure,or clinically significant abnormal laboratory tests (including hypokalemia,hypercalcemia, or hypomagnesemia) identified at Screening.

• Presence of abnormal serum virology at screening;

1. Active hepatitis, or hepatitis B surface antigen (HBsAg) positive, or HepatitisC virus (HCV) antibody positive;

2. Positive for Human immunodeficiency virus (HIV) antibody at the screeningstage, or previous history of HIV infection;

3. Positive antibodies to Treponema pallidum in screening.

• Presence of active tuberculosis during the Screening Period, or being a closehousehold contact of a patient with untreated active tuberculosis, or having apositive tuberculosis interferon gamma release assay (TB-IGRA) by laboratoryexamination.

• A history of severe bacterial, fungal or viral infection requiring hospitalizationfor intravenous antibiotic or antiviral medication within 2 months prior torandomization.

• Live vaccination within 4 weeks prior to randomization or planning to receive a livevaccine during the study.

• The presence of clinically significant infections during the Screening Period,including but not limited to upper respiratory tract infections, lower respiratorytract infections, herpes simplex, herpes zoster, and requiring treatment withantibiotics or antiviral medications.

• A history of severe herpes zoster or herpes simplex infection including, but notlimited to, herpes encephalitis, disseminated herpes simplex, and herpes zosterpandemic.

• Use of any systemic cytotoxic or systemic immunosuppressive drug within 6 monthsprior to randomization, or use of any topical cytotoxic or topical immunosuppressivedrug within 4 weeks or 5 half-lives (whichever is longer) prior to randomization.

• Receipt of a biologic or other clinical trial drug within 3 months or 5 half-lives,whichever is longer, prior to randomization.

• Has undergone surgery within 4 weeks prior to randomization or is scheduled toundergo surgery during the study.

• Who has lost or donated more than 400 mL of blood within 4 weeks prior torandomization.

• Who have taken any prescription, over-the-counter, and herbal medications, exceptvitamin products, within 4 weeks prior to randomization.

• Persons with potential blood collection difficulties and a history of needle andblood sickness.

• Allergy to any of the known components of TQH3906 or any previous history of severedrug allergy.

• History of substance abuse or positive urine drug screen.

• Who have smoked more than 5 cigarettes/day or used an equivalent amount of nicotineor nicotine-containing products in the 3 months prior to randomization, or who areunable to discontinue the use of any tobacco-based products during the trial.

• Those who have chronic alcohol abuse or who have consumed more than 14 units ofalcohol per week (1 unit = 360 mL of beer or 45 mL of spirits of 40% alcohol byvolume or 150 mL of wine) in the 3 months prior to screening or who are unable toabstain from alcohol for the duration of the trial, or who have a positive breathtest for alcohol.

• Have any other valid medical, psychiatric, or social reason that, in the opinion ofthe investigator, precludes participation in this study.