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This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of IBI355 in primary Sjogren's syndrome (pSS) patients. This study also aims to evaluate the anti-Drug antibody after multiple ascending doses of IBI355 in pSS patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI355 7.5mg/kg | Experimental | IBI355 7.5mg/kg and placebo will be given to the subjects every 4 weeks (8:2) |
|
| IBI355 15mg/kg | Experimental | IBI355 15mg/kg and placebo will be given to the subjects every 4 weeks (8:2) |
|
| IBI355 30mg/kg | Experimental | IBI355 30mg/kg and placebo will be given to the subjects every 4 weeks (8:2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI355 | Drug | IBI355 IV. Q4W |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events and serious adverse events | up to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the Curve(AUC) of multi-dose of IBI355 | Up to week 16 | |
| Peak serum concentration(Cmax) of multi-dose of IBI355 | Up to week 16 | |
| Clearance (CL) of multi-dose of IBI355 |
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Inclusion Criteria:
Exclusion Criteria:
6.Patients with a history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders and other systemic diseases; 7. Subject with a hcg positive; 8.Patients with a history of neuropsychiatry or who are considered unfit to participate in this clinical trial; 9.Patients with pulmonary interstitial fibrosis, or those requiring combined antifibrotic drug therapy, or those with abnormal lung function that the investigators determined was not suitable for this study; 10. Need to use other drugs that could cause xerostomia during the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of University of Science and Technology of China | Hefei | Anhui | 230001 | China |
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| IBI355 placebo |
| Drug |
IBI355 placebo IV. Q4W |
|
| Up to week 16 |
| Half-life (t1/2) of multi-dose of IBI355 | Up to week 16 |
| The ratio of Anti-drug antibody of multi-dose of IBI355 | Up to week 24 |