Post-transplantation rejection
Conditions
Interventions
50 mg(iv):3 cases were given SHR-2106 intravenously, 2 cases were given placebo
150 mg(iv) :3 cases were given SHR-2106 intravenously, 2 cases were given placebo
300 mg(iv):6 cases were given SHR-2106 intravenously, 2 cases were given placebo
600 mg(iv):6 cases were given SHR-2106 intravenously, 2 cases were given placebo
1200 mg(iv):6 cases were given SHR-2106 intravenously, 2 cases were given placebo
1800 mg (iv, optional):6 cases were given SHR-2106 intravenously, 2 cases were given placebo
300 mg(sc):6 cases were given SHR-2106 intravenously, 2 cases were given placebo
600 mg(sc,optional):6 cases were given SHR-2106 intravenously, 2 cases were given placebo
Sponsors
Clinical Trial Center of Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. obtain informed consent prior to the commencement of any activity related to the trial and have a full understanding of the purpose and significance of this trial Full understanding and willingness to comply with the trial protocol; 2. be aged 18 ~ 55 years (including borderline values), male and female; 3. male weight = 50 kg, female weight = 45 kg, body mass index (BMI) = weight (kg)/height 2 (m2), BMI in the range of 0.5 to 0.5, BMI in the range of 0.5 to 0.5. (Body mass index (BMI) = weight (kg)/height 2 (m2 ), BMI within the range of 19 ~ 28 kg/m2 (including boundary value). 4; 4. Pre-random physical examination, vital signs, laboratory tests (routine blood, urine, blood biochemistry, coagulation function), thyroid function, blood glucose, blood glucose, blood glucose, blood glucose, blood glucose, blood glucose, blood glucose, blood glucose, blood glucose, blood glucose, blood glucose and blood glucose. (blood, urine, blood biochemistry, coagulation), thyroid function, chest radiographs, and 12-lead electrocardiograms were normal or abnormal without clinical significance; 5. subjects and their partners during the study period until after the last dose of the trial (see Table 9 for final follow-up between dose groups). 9 months (female subjects treated with SHR-2106) or 6 months (male subjects treated with SHR-2106) without having a child. No birth plan within 9 months (for female subjects treated with SHR-2106) or 6 months (for male subjects treated with SHR-2106), no sperm/egg donation, and voluntary use of highly effective contraception (see Annex 1 of the programme for details). The female subject must have a negative serum pregnancy test and not be lactating.
Exclusion criteria
Exclusion criteria: 1. Subjects will be screened with a history, symptoms and test results suggestive of active or latent tuberculosis. Subjects will be screened by Interferon gamma release assay (IGRA) and frontal and lateral chest radiographs (X-rays). All subjects will be screened for TB status. Subjects who had an IGRA and X-ray within 1 month prior to screening were screened for TB based on the investigator's opinion. Subjects who have had an IGRA and X-ray within 1 month prior to screening may, at the investigator's discretion, not repeat the IGRA and X-ray at the time of screening; ? IGRA test results are not negative; ? If the IGRA result is inconclusive, retesting is permitted. Subjects with 2 inconclusive test results will be excluded from the study. Subjects with 2 indeterminate results will be excluded from the study; 2. previous history (within 5 years) of serious cardiovascular, hepatic, renal, gastrointestinal, psychoneurological, haematological or metabolic abnormalities. 2. prior history of serious cardiovascular, hepatic, renal, gastrointestinal, psychoneurological, haematological, metabolic abnormalities, etc; 3. have had a serious infection, serious trauma, or major surgical procedure within 6 months prior to screening or dosing; are scheduled to undergo surgery during the trial; or are scheduled to undergo surgery during the trial. (c) A history of metabolic abnormalities (within 5 years); 3; 4. chronic or recurrent infections requiring treatment within 12 months prior to screening; 5. have donated or lost = 200 mL of blood within 1 month prior to screening or dosing, or = 400 mL of blood within 3 months prior to dosing. Blood donation or loss within 1 month prior to screening or administration of the drug, or blood donation or loss within 3 months prior to administration of the drug, totalling = 400 mL, or who have received a blood transfusion within 2 months; 6. a history of allergy to two or more dietary medications; or a known allergy to the study drug or any component of the study drug (see Annex 2 of the protocol for injectable components). (6. History of allergy to two or more dietary medications; or known allergy to the study drug or any component of the study drug (see Annex 2 of the protocol for injectable components) 7. a history of tobacco use, defined as an average of 5 or more cigarettes per day, within 3 months prior to screening; or an inability to comply with a smoking ban during the study; and 7. a history of tobacco use within 3 months prior to screening, defined as an average of more than 5 cigarettes per day, or inability to comply with a smoking ban during the study period 8. a history of alcohol use (intake of more than 15 g of alcohol per day for women and more than 25 g of alcohol per day for men [5 g alcohol (more than 15 g of alcohol for women and more than 25 g of alcohol for men in a day [5 g of alcohol equivalent to 150 mL of beer, 50 mL of wine, or approximately 17 mL of low proof liquor] more than twice a week) or a positive breath test for alcohol at baseline positive breath test for alcohol at baseline; 9. Systolic blood pressure (SBP) prior to screening or administration: SBP = 140 mmHg or < 90 mmHg; diastolic blood pressure (DBP): DBP = 90 mmHg or < 50 mmHg. 10; 10. = 2 times the upper limit of the normal range (ULN) for alanine aminotransferase (AST) or alanine aminotransferase (ALT) at screening. or total bilirubin = 1.5 times the ULN. 11; 11. persons with clinically significant coagulation abnorma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vital signs;Physical examination;Twelve-lead electrocardiogram;laboratory test;adverse event;Pregnancy Tests;Plasma concentration;AUC0-t;AUC0-inf;Cmax;Tmax;t?;CL( CL/F);Vss( Vz/F) ;Incidence of ADA;CD40 receptor occupancy on the surface of B cells in peripheral blood; | — |
Countries
China
Contacts
Public ContactGuoping Yang
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Outcome results
None listed