LISCure Biosciences
The study is designed to assess the safety and efficacy of LB-P8 in patients with primary sclerosing cholangitis.
This is phase 2, randomized, double-blind, placebo-controlled, multicenter study to assess the safety and efficacy of LB-P8 in adult patients with primary sclerosing cholangitis(PSC). * Part 1 will evaluate safety and tolerability of 2 pre-selected dose level of LB-P8 (low-dose\[1×10\^10 CFU/capsule\] and high dose \[1×10\^11 CFU/capsule\]) in adult patients with PSC. Part 1 plans to enroll a maximum number of 12 patients based on a "3+3" study design. * Part 2 will evaluate safety and efficacy in adult patients with PSC. Eligible patients with PSC will be randomized in a 1:1:1 ratio to recei…
Inclusion Criteria: * Age: 18 to 75 years * A diagnosis of PSC based on cholangiographic evidence of PSC in accordance with American Association for the Study of Liver Diseases (AASLD) guidelines * ALP \>1.5 times the ULN at screening * PSC with or without IBD, such as ulcerative colitis or Crohn's disease * If patients are being administered biologic or advanced therapeutic treatments, immunosuppressants, systemic corticosteroids, obeticholic acid, fibrates, or statins, they must be on a stable dose for ≥3 months prior to, and including, Day 0 and plan to remain on a stable dose throughout t…
One capsule QD (1×10\^10 CFU/day) oral administration
One capsule QD (1×10\^11 CFU/day) oral administration
One capsule QD oral administration