A phase 1, single-dose study of fresolimumab, an anti- XXXX antibody, in treatment-resistant primary @entity628 .

@entity1 @entity644 @entity4969 @entity628 @entity2533 @entity1011
Primary @entity628 ( @entity628 ) is a disease with poor prognosis and high unmet therapeutic need. Here, we evaluated the safety and pharmacokinetics of single-dose infusions of fresolimumab, a human monoclonal antibody that inactivates all forms of @entity2533 ( @entity2533 ), in a phase I open-label, dose-ranging study. @entity1 with biopsy-confirmed, treatment-resistant, primary @entity628 with a minimum estimated glomerular filtration rate (eGFR) of 25    ml/min per 1.73    m(2), and a urine protein to @entity1011 ratio over 1.8    mg/mg were eligible. All 16 @entity1 completed the study in which each received one of four single-dose levels of fresolimumab (up to 4    mg/kg) and was followed for 112 days. Fresolimumab was well tolerated with pustular rash the only adverse event in two @entity1 . One @entity1 was diagnosed with a histologically confirmed primitive @entity4969 2 years after fresolimumab treatment. Consistent with treatment-resistant @entity628 , there was a slight decline in eGFR (median decline baseline to final of 5.85   ml/min per 1.73    m(2)). @entity644 fluctuated during the study with the median decline from baseline to final in urine protein to @entity1011 ratio of 1.2    mg/mg with all three Black @entity1 having a mean decline of 3.6    mg/mg. The half-life of fresolimumab was    14 days, and the mean dose-normalized Cmax and area under the curve were independent of dose. Thus, single-dose fresolimumab was well tolerated in @entity1 with primary resistant @entity628 . Additional evaluation in a larger dose-ranging study is necessary.
