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To evaluate the safety and tolerability of three dose regimens of budoprutug in subjects with PMN
Confirmed diagnosis of PMN with positive anti-PLA2R antibodies [+8]
Secondary Membranous Nephropathy [+8]
Budoprutug is a humanized, immunoglobulin (Ig) G1 monoclonal antibody that selectively binds to CD19 and is projected to deplete targeted cells through antibody-dependent cellular cytotoxicity. This Phase 1b/2a, open-label study will evaluate budoprutug in ascending dose cohorts of patients aged 18 years and above with active, seropositive SLE and inadequate response to standard therapy. The study will also assess the pharmacokinetics, pharmacodynamics and early indications of efficacy of budoprutug in SLE, where pharmacodynamics will be evaluated as the change in the number of B cells and immunoglobulins (antibodies) in the blood over time. Budoprutug will be administered as two (2) IV infusions 14 days apart in ascending dose cohorts.
Aged 18 to 65 years at the time of consent. [+3]
Active neuropsychiatric SLE. [+3]
The main objective is to assess the safety and tolerability of budoprutug in adults with ITP. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.
Aged 18 years at the time of consent. [+2]
CD19+ B cell count < 80 cells/µL at Screening, or < 40 cells/µL if B-cell deplet... [+8]
The main objective is to assess the safety and tolerability of budoprutug in adults with SLE. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.
Aged 18 to 65 years at the time of consent. [+3]
Active neuropsychiatric SLE. [+2]
This Phase 1, first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CLYM116 in healthy volunteers.
Healthy adult males and females aged 18-60 years, inclusive [+6]
Prior treatment with investigational drugs within 30 days or 5 half-lives [+5]