141
Participants
Start Date
August 22, 2023
Primary Completion Date
December 31, 2029
Study Completion Date
December 31, 2029
CYH33
CYH33: Participants will receive oral CYH33 once daily. The starting dose for adults in Phase I is 10 mg QD; adolescents begin at 5 mg QD. In Phase II, patients will receive RP2D determined in the Phase I study.
Placebo
Placebo: Matching placebo tablets will be administered once daily during the double-blind period of the Phase II PRVM cohort. Patients randomized to placebo will switch to CYH33 at the end of the blinded phase.
RECRUITING
Capital Institute of Pediatrics, Beijing
RECRUITING
Plastic Surgery Hospital, Chinese Academy of Medical Sciences, Beijing
RECRUITING
Shanghai Ninth People Hospital, Shanghai Jiaotong University School of Medicine, Shanghai
RECRUITING
West China Hospital of Sichuan University, Chengdu
Lead Sponsor
Haihe Biopharma Co., Ltd.
INDUSTRY