A Multicenter, Open-label Phase II Clinical Trial Evaluating the Efficacy and Safety of SYH2070 Injection in Chinese Participants With Homozygous Familial Hypercholesterolemia
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This trial is a multicenter, open-label, phase II clinical study, aiming to evaluate the efficacy and safety of SYH2070 injection in participants with HoFH.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18 years old, male or female, and weight ≥40 kg.
• Genetic diagnosis or clinical diagnosis of HoFH.
• Receiving stable and tolerable lipid-lowering treatment or other drugs for chronic disease treatment for certain periods before the study, and maintaining the stable -treatments throughout the study.
• Fasting serum LDL-C ≥2.6 mmol/L.
• Fasting TG during screening is ≤5.6 mmol/L
• BMI\< 40 kg/m ² during screening
• Understand the study procedures, voluntarily participate, and sign the informed consent form.
Locations
Other Locations
China
The Second Xiangya Hospital
RECRUITING
Changsha
Contact Information
Primary
Clinical Trials Information Group officer
ctr-contact@cspc.cn
0311-69085587
Time Frame
Start Date: 2026-05-24
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 18
Treatments
Experimental: SYH2070 injection dose1
SYH2070 injection dose2
Experimental: SYH2070 injection dose2
SYH2070 injection
Related Therapeutic Areas
Sponsors
Leads: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.