72
Participants
Start Date
March 11, 2024
Primary Completion Date
January 24, 2026
Study Completion Date
March 1, 2026
FD-001
"The initial dose was 0.4mg, and subsequent doses of 0.8mg, 1.6mg, 2.4mg, 3.2mg, and 4.0mg were proposed to be administered in a progressive manner using the rapid titration method combined with the traditional 3+3 experimental design. The trial process consists of three periods: screening period, treatment period, and follow-up period. The screening period lasted from D-28 to D-1 for treatment (DLT observation period): during this time frame, there was a single administration period (C0D1-C0D4) where oral administration occurred on day one followed by safety observations on days two to four; as well as multiple administration period one (C1D1-C1D28) where oral administration took place on days one to two and seven to nine with rest periods in between. The drug is available in capsule form."
RECRUITING
West China Hospital of Sichuan University, Chengdu
Lead Sponsor
Chengdu FenDi Pharmaceutical Co., Ltd.
INDUSTRY