Safety and Tolerability of IBI355 in Patients With Primary Sjogren's Syndrome (NCT06484855) | Clinical Trial Compass
CompletedPhase 1
Safety and Tolerability of IBI355 in Patients With Primary Sjogren's Syndrome
China30 participantsStarted 2024-07-14
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Understand and sign the informed consent form;
✓. Age ≥ 18 years, male or female；
✓. Body Mass Index (BMI) within the range of 18.0 to 28.0 kg/m² (inclusive);
✓. Meet the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for Sjögren's Syndrome;
✓. Positive for anti-Sjögren's syndrome A autoantibodies (SSA) and/or anti-Sjögren's syndrome B autoantibodies (SSB);
. HIV-Ab、RPR、HCV-Ab、HBV、HBeAg or HBcAb, one of them positive;
✕. There have a clinical or imaging evidence that the subject with active tuberculosis, or there is evidence that the subject is in the incubation period for tuberculosis;
✕.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.