13
Participants
Start Date
June 10, 2025
Primary Completion Date
June 30, 2027
Study Completion Date
June 30, 2027
OPF-310
"Dose(Part1): 6,000 islet equivalents (IEQ)/kg or 12,000 islet equivalents (IEQ)/kg~Dose(Part2): Recommended Phase II Dose(RP2D), which will be determined based on the data of Part1~* In Part1, three subjects will be enrolled into the first dosing cohort (Cohort 1: 6,000 IEQ/kg) and they will undergo safety monitoring. Three subjects in Cohort 2 will be dosed with 12,000 IEQ/kg and will undergo safety monitoring.~* In Part2, 7 subjects will be enrolled into the Part 2 dose-expansion part."
RECRUITING
University of Illinois Hospital &Health Scences System, Chicago
Lead Sponsor
Otsuka Pharmaceutical Factory, Inc.
INDUSTRY