A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC
Part of paid clinical trials in Sacramento, California.
- Sponsor
- LISCure Biosciences
- Study ID
- NCT06699121
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Primary Sclerosing Cholangitis (PSC)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- LB-P8 low-dose — DRUGOne capsule QD (1×10\^10 CFU/day) oral administration
- LB-P8 high-dose — DRUGOne capsule QD (1×10\^11 CFU/day) oral administration
- Placebo — DRUGOne capsule QD oral administration
Study Details
The study is designed to assess the safety and efficacy of LB-P8 in patients with primary sclerosing cholangitis.
Key Dates
- Start date
- Nov 30, 2025
- Status verified
- Oct 2025
- Primary completion
- Mar 31, 2028
- Completion
- Feb 28, 2029
Study Design
- Enrollment
- 87 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: LB-P8 low-doseOral capsule, 1×10\^10 CFU/day
- Experimental: LB-P8 high-doseOral capsule, 1×10\^11 CFU/day
- Placebo Comparator: PlaceboOral capsule, placebo
Primary Outcome Measure
Safety and tolerability of 2 different doses of LB-P8 [ Time Frame: (Part 1) Up to 4 weeks of treatment from the Baseline ]
Central Contacts
- LISCure Biosciences Clinical Trials+82317061710
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California Davis | Sacramento | California | 95817 | University of California Davis 800-282-3284 Christopher Bowlus, MD (PRINCIPAL_INVESTIGATOR) |
| UCHealth University of Colorado Hospital | Aurora | Colorado | 80045 | UCHealth University of Colorado Hospital 7208480000 Lisa Forman, MD (PRINCIPAL_INVESTIGATOR) |
| University Of Iowa Hospitals And Clinics | Iowa City | Iowa | 52242 | University Of Iowa Hospitals And Clinics 319-356-1616 Alan Gunderson, MD (PRINCIPAL_INVESTIGATOR) |
| Mercy Medical Center | Baltimore | Maryland | 21202 | Mercy Medical Center 410-332-9000 Paul Thuluvath, MD (PRINCIPAL_INVESTIGATOR) |
| Mayo Clinic | Rochester | Minnesota | 55905 | Mayo Clinic 507-284-2511 John Eton, MD (PRINCIPAL_INVESTIGATOR) |
| The Vanderbilt Clinic | Nashville | Tennessee | 37232 | The Vanderbilt Clinic 615-322-5000 Manhal Izzy, MD (PRINCIPAL_INVESTIGATOR) |
| Liver institute Northwest | Seattle | Washington | 98105 | Kris Kowdley, MD (PRINCIPAL_INVESTIGATOR) |