Inflammatory bowel disease,IBD
Conditions
Interventions
Cohort 1 (S1 group):EP-0210 monoclonal antibody injection, 1mg, single intravenous administration (n=2)
Cohort 2 (S2 group):EP-0210 monoclonal antibody injection, 5mg, single intravenous administration (n=3) or placebo (n=1)
Cohort 3 (S3 group):EP-0210 monoclonal antibody injection, 25mg, single intravenous administration (n=6) or placebo (n=2)
Cohort 4 (S4 group):EP-0210 monoclonal antibody injection, 100mg, single intravenous administration (n=6) or placebo (n=2)
Cohort 5 (S5 group):EP-0210 monoclonal antibody injection, 300mg, single intravenous administration (n=6) or placebo (n=2)
Cohort 6 (S6 group):EP-0210 monoclonal antibody injection, 600mg, single intravenous administration (n=6) or placebo (n=2)
Cohort 7 (S7 group):EP-0210 monoclonal antibody injection, 900mg, single intravenous administration (n=6) or placebo (n=2)
Cohort 8 (S8 group):EP-0210 monoclonal antibody injection, 1200mg, single intravenous administration (n=6) or placebo (n=2)
Cohort 9 (M1 group):EP-0210 monoclonal antibody injection, 300mg every 2 weeks (Q2W), intravenous administration (n=6) or placebo (n=2)
Cohort 10 (M2 group):EP-0210 monoclonal antibody injection, 600mg every 2 weeks (Q2W), intravenous administration (n=6) or placebo (n=2)
Cohort 11 (M3 group):EP-0210 monoclonal antibody injection, 900mg every 2 weeks (Q2W), intravenous administration (n=6) or placebo (n=2)
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Participants for the China Health Study, male or female, aged 18 to 45 years inclusive. 2. Body Mass Index (BMI) within the range of 19.0 to 26.0 kg/m^2 [BMI = weight (kg) / height^2 (m^2)] (including the boundary values); 3. Participants (including male trial participants) must be willing to have no plans for conception and to voluntarily use effective non-pharmacological contraceptive measures (see Appendix) from two weeks prior to screening until six months after the final administration of the study drug, and must have no plans for sperm or egg donation; 4. Sign an informed consent form prior to screening, fully understand the trial content, procedures, and potential adverse reactions, and be able to complete the study in accordance with the trial protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Individuals with clinically manifest abnormalities requiring exclusion prior to screening, including but not limited to those with disorders affecting the nervous/psychiatric system, respiratory system, cardiovascular system, gastrointestinal tract (including any history of gastrointestinal disease affecting drug absorption), haematopoietic and lymphatic systems, hepatic and renal function, endocrine system, or immune system; 2. Clinical findings of significance from vital signs assessment, physical examination, clinical laboratory tests (complete blood count, urinalysis, blood biochemistry, coagulation profile), immunological testing, pregnancy assessment (females only), and 12-lead electrocardiogram; 3. Any positive result for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or treponemal antibody panel (TPPA) during screening; 4. Screening for a history of herpes zoster infection within the preceding two months; 5. Based on clinical symptoms and/or chest imaging findings, it is determined that trial participants may have active Mycobacterium tuberculosis (TB) infection (with evidence indicating that prior active TB infection has been adequately treated and deemed eligible for inclusion following investigator assessment); 6. Individuals who have had an acute upper respiratory tract infection within the preceding two weeks; 7. Individuals who have undergone surgery within the three months preceding screening, or who are scheduled to undergo surgery during the study period, or who have undergone procedures affecting the absorption, distribution, metabolism, or excretion of medicinal products; 8. A history of allergies to foods, medications, or other substances, or a known allergy to this product and its excipients; 9. History of heparin sensitivity or heparin-induced thrombocytopenia prior to screening; 10. Individuals who have used any prescription medication, over-the-counter medication, herbal remedies, or vitamins within the preceding month or five elimination half-lives (whichever is longer); 11. Individuals who have received a vaccination within the preceding month, or who plan to undergo vaccination during the study period; 12. Individuals who, in the three months prior to screening, consumed an average of more than 14 units of alcohol per week (1 unit of alcohol ˜ 360 mL of beer or 45 mL of 40% strength spirits or 150 mL of wine), or who are unable to abstain from alcohol during the trial period; 13. Individuals who, prior to screening, averaged more than five cigarettes per day over the preceding three months, or who are unable to abstain from any tobacco products during the trial period; 14. Individuals who have donated blood, including component blood or experienced significant blood loss (=400 mL), or received any blood product within the preceding three months shall be excluded; 15. Individuals with a history of drug abuse, drug dependence, illicit drug use, or a positive drug screening result prior to screening; 16. Exclude subjects who have participated in other drug or device clinical trials within the preceding three months or five elimination half-lives (whichever is longer), or who were enrolled in a clinical trial by someone other than themselves; 17. Individuals with special dietary requirements who cannot accept standardised meals; 18. Individuals unable to tolerate venous puncture or with a history of needle ph
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability outcomes; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK outcome;Immunogenicity outcomes; | — |
Countries
China
Contacts
Public ContactHu Wei
The Second Hospital of Anhui Medical University
Outcome results
None listed