MSC303 Subcutaneous Injection for the Treatment of Immunologic Glomerular Disease.
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShanghai Changzheng Hospital
About this trial
This study will evaluate the safety and efficacy of MSC303 in patients with Immune glomerular diseases.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 to 65 years (including boundary values), gender unspecified；
Willing to participate voluntarily in this clinical study and with good compliance；
Diagnosed with lupus nephritis(LN);
diagnosed with ANCA-associated glomerulonephritis (ANCA-GN);
Disqualifiers
History of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of MSC303；
Active infection requiring antibiotic treatment；
Concomitant with other serious diseases；
Patients with congenital immunoglobulin deficiency；
Trial design
Design model
Single group
Treatments tested in this trial
Injection of MSC303
DrugDose Group 1: D1, D8, D15, and D36 were respectively given 1, 5, 15, and 15 mg of MSC303 for injection; The second dose group: D1, D8, D15 and D36 were respectively given for injection MSC303 1, 5, 20, 20 mg.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: MSC303Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Phase Ib: safety Phase II: Urine Protein/Creatinine Ratio (UPCR)
Phase Ib: To evaluate the safety of MSC303 for injection in subjects with immune glomerular diseases. Phase II: To evaluate the change in Urine Protein/Creatinine Ratio (UPCR) from baseline at Week 12.
Time frame
12 weekSponsors and contacts
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Source ClinicalTrials.gov
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