Ulcerative colitis
Conditions
Interventions
Group1:HX15001 300mg injection
Group3 Placebo control group:palcebo
Group2:HX15001 750mg injection
Group1 Placebo control group:placebo
Group3:HX15001 1050mg injection
Group2 Placebo control group:placebo
Sponsors
Second Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Male and female participants must be at least 18 and no more than 45 years old (inclusive) when signing the informed consent form. 2. The subjects (including male subjects) are willing to undergo screening until 6 months after the last administration of the study drug, have no intention to have children within this period, and voluntarily adopt effective non-drug contraceptive measures (refer to Chapter 8.1), and have no plans for sperm donation, egg donation, or other forms of in vitro reproduction. 3. Subjects who are willing and able to follow all the prescribed medication schedules, follow-up plans, laboratory tests, lifestyle requirements, and other research procedures. 4. Body Mass Index (BMI) ranging from 19 to 26 kg/m2 (inclusive of both ends); total weight >= 50 kg. Able to sign the informed consent form, including compliance with the requirements and restrictions listed in the informed consent form and this protocol.
Exclusion criteria
Exclusion criteria: 1.There is evidence or medical history of clinically significant diseases in the blood, kidneys, endocrine system, lungs, gastrointestinal tract, cardiovascular system, liver, mental state, nervous system or allergic reactions (including drug allergies or food allergies, but excluding untreated, asymptomatic, or seasonal allergies during administration). 2. The results of the eight infection tests (hepatitis B virus surface antigen, hepatitis B virus surface antibody, hepatitis B virus e antigen, hepatitis B virus e antibody, hepatitis B virus core antibody, hepatitis C virus antibody, human immunodeficiency virus antibody, Treponema pallidum specific antibody) showed abnormal values with clinical significance. 3. During the screening visit, check for any recent symptoms of infection that have persisted or recurred within the past 28 days, or for any active infection history that can be confirmed through laboratory tests. 4. Subjects who have suffered from acute diseases within 48 hours prior to administration. 5. History of tuberculosis or history of active, latent or inadequately treated infection. There is evidence suggesting untreated or inadequately treated active or latent Mycobacterium tuberculosis. The evidence of tuberculosis infection is as follows: ? Those with abnormal results in the screening T-Spot test that have clinical significance. ? Chest X-ray films taken within 3 months before screening showing active tuberculosis infection. 6. Review the use of prescription or over-the-counter medications, as well as dietary and herbal supplements, within the 5 half-lives (whichever is longer) of the most recent 7 days or the duration of the prescribed medication. 7. Within 28 days prior to the screening visit, the participant had received or was scheduled to receive an live vaccine during the study period. 8. Subjects who were exposed to any type of antibody or anti-TL1A therapy before screening and are still within their 5 to 7 half-life periods. 7. Within 28 days prior to the screening visit, the participant had received or was scheduled to receive an live vaccine during the study period. 9. The female is in the lactation period or during pregnancy or the pregnancy test result is positive. 10. The baseline 12-lead electrocardiogram shows clinically relevant abnormalities that may affect the safety of the subjects or the interpretation of the research results. If the baseline uncorrected QT interval is > 450 ms, the Fridericia method should be used to heart rate-correct the interval, and the resulting QTcF should be used for decision-making and reporting. If the QTc exceeds 450 ms (for males) / 460 ms (for females), or the QRS exceeds 120 ms, the electrocardiogram should be repeated twice, and the average of the three QTc or QRS values should be used to determine the eligibility of the subjects. 11. Physical examination, general physical assessment, clinical laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function), chest anteroposterior X-ray, etc. Any abnormal results with clinical significance will be recorded. 12. According to the CKD - EPI 2021 formula, eGFR is less than 80 mL/min/1.73 mm2. 13. Positive results were obtained from drug screening during the screening or baseline visit, or there was a history of drug abuse in the past 2 years. 14. During the past year, those who consumed more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol content l
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax of HX15001;AUCinf of HX15001;t1/2 of HX15001;Tmax of HX15001;Safe index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics; | — |
Countries
China
Contacts
Public ContactZhihong Xie
Second Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed