A Study of Single and Multiple Oral Doses of TollB-001

Inclusion Criteria:

1. Healthy male and female subjects between the age of 18 and 45 (both inclusive) whensigning the informed consent form (ICF)
2. Able to give a signed written ICF (the consent form must be signed by the subjectprior to any study-specific procedures); have a full understanding of the studycontent, procedures, and possible AEs; and be willing and able to comply with studyprocedures and follow-up examinations
3. Body mass index (BMI, weight [kg]/height2 [m2]) within 19.0-26.0 kg/m2 (bothinclusive), with total body weight > 50 kg for male subjects and > 45 kg for femalesubjects.
4. The subjects must be willing to use efficient physical contraception methods with acontraceptive failure rate of<1% with their reproductive age partners within 90 daysfrom signing the ICF to the last administration of the investigational drug (such ascondoms , intrauterine devices)
5. Male subjects must also be willing to refrain from donating sperm for 90 days from thefirst administration of the investigational drug to the last administration of theinvestigational drug
6. Results of vital signs, physical examination, laboratory examinations, abdominal andurinary B-ultrasound, 12-lead ECG, and other examination are normal or abnormal butnot clinically significant. QT interval corrected for heart rate according toFridericia's formula (QTcF) must be within the following ranges: QTcF ≤ 450 msec formale subjects, and QTcF ≤ 470 msec for female subjects. Assessment may be repeated ifdeemed appropriate by the investigator.
7. Ability to swallow all IMPs.

Exclusion Criteria: Subjects were excluded if they meet any of the following exclusion criteria:

1. Known or suspected allergy or hypersensitivity to any component of TollB-001, knownallergic constitution or allergy to two or more foods or drugs.
2. Severe gastrointestinal diseases, such as patients who have undergone majorgastrointestinal surgery that would potentially alter absorption and/or excretion oforally administered drugs (except for cholecystectomy, appendectomy, hernia repair),or medical history of ulcer, gastrointestinal bleeding, gastritis, etc.
3. History or clinical manifestations of any clinically significant gastrointestinal,gallbladder or biliary tract, renal, urologic, pulmonary, neurological,cardiovascular, endocrinological, hematological, immunologic, dermatologic, metabolicdisorder, or psychiatric disease (as determined by the investigator).
4. Current or chronic history of liver disease or known hepatic ,or clinicallysignificant of biliary abnormalities , or clinically significant abnormal results ofliver function test at screening, including alanine amino transferase (ALT) or/andaspartate aminotransferase (AST) > 1.5 × upper limit of normal (ULN)or/and totalbilirubin > ULN.
5. eGFR < 90 mL/min/1.73 m2 calculated using the Chronic Kidney Disease EpidemiologyCollaboration (CKD-EPI) equation at screening or on Day-1.
6. Current or history of clinically significant cardiac arrhythmias (symptomatic orasymptomatic).
7. Serious infection within 3 months prior to dosing or symptoms of infection within 7days before dosing, including acute and chronic infections and local infections (bacterial, viral, parasitic, fungal, or other opportunistic pathogens), which isinappropriate to participant as deemed by the investigator.
8. Major illness or surgery within 3 months before dosing ,or planned surgery during thestudy period.
9. Intolerance to venipuncture.
10. Participation in any clinical study or received any other investigational product ordevice within 4 weeks prior to the first dose or 5 times the half-life of the specificdrug/biologics(whichever is longer), or plan to take an investigational agent duringthe study.
11. Donated blood > 400 mL or significant blood loss (equivalent to 400 mL), or receivedblood transfusion within 3 months of prior to screening, or have plans to donate bloodduring the study.
12. History of malignancy within 5 years prior to screening (excluding non-melanoma skincancer that has been resected).
13. Positive results of any of the following tests at screening: serum hepatitis B surfaceantigen (HBsAg), hepatitis C virus (HCV RNA or HCV antibodies [Ab]), humanimmunodeficiency virus 1 and 2 (HIV)Ab, or Treponema pallidum (TP) Ab.
14. Active tuberculosis (TB) infection indicated by chest radiography orγ-interferon atscreening or within 3 months prior to screening. TB test positive, or active or latentTB infection as discretion of the investigator according to clinical practice, orhistory of TB, or currently receiving treatment for this disease.
15. Plans to receive administration of any live vaccine within 4 weeks before dosing or upto 30 days after the last dose of IMP.
16. Use of drugs, including prescription, over-the-counter medications herbal products,vitamins, and minerals, within 2 weeks prior to the first dose or within 5 times theelimination half-life of the medication prior to first dosing（whichever is longer）.
17. Participated in strenuous exercise from 48 hours prior to Day-1 .
18. Unwilling to refrain from any food or beverage containing caffeine or producingxanthine after metabolism (e.g., tea, coffee, chocolate, cola, red cattle) from 24hours prior to Day -1 and during the study.
19. Use of food or beverages likely to influence liver metabolism, within 14 days prior tothe first dose of the IMP (e.g., star fruit, pomelos, grapefruit, and Sevilleoranges). Use of any drugs or nutrients known to modulate cytochrome P450 (CYP) 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A and transporter OATP1B1,1B3, OAT3, OCT2 activity (referto Appendix 3) or any strong or moderate inhibitors or inducers ofCYP1A2, BCRP,OATP1B1, OATP1B3, and OAT3 (refer to Appendix 4) starting from 14 days priorto doseadministration on Day 1.
20. History of significant alcohol abuse within 6 months prior to screening or use of morethan 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of alcohol 40% or 150 mL of wine) within 90 days prior to screening or alcohol breath test >0.0mg/100mlat screening, or unwilling to refrain from consumption of alcohol during the study.
21. Use of tobacco or nicotine products or smoking within 90 days (more than 5 cigarettesper day) prior to screening and unwilling to refrain from 24 hours prior to Day -1 andduring the study.
22. Drug abuse or those who have taken drugs (such as cocaine, phencyclidine, etc.) withinone year prior to screening (consultation); Or those who are positive for urine drugabuse screening (methamphetamine, ketamine, MDMA ,tetrahydrocannabinoid acid,morphine) during screening.
23. Women who are lactating or positive pregnancy test within at screening or during thestudy period, or planning to become pregnant during the study period.
24. Acute illness occurs or concomitant medication required from screening to dosing.
25. Constipated or irregular bowel movements.
26. Any other situation that researchers believe may affect the subject's ability toprovide informed consent or follow the trial protocol, or the subject's participationin the trial may affect the trial results or their own safety.