Status:
RECRUITING
A Study of SRSD216 in Patients With Elevated Lipoprotein (a)
Lead Sponsor:
Sirius Therapeutics Co., Ltd.
Conditions:
Hyperlipoproteinemia (a)
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a two-part study, intended to investigate the safety, tolerability, characteristics of PK and PD of single SC dose of SRSD216 and to identify a dose range for further studies in subjects with ...
Eligibility Criteria
Inclusion
- Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions;
- Males or females, of any race;
- Body mass index (BMI) between 18.0 and 40.0 kg/m2, inclusive;
- Male subjects are not allowed to donate sperm, and female subjects are not allowed to donate eggs from the time the ICF is signed until at least 3 months after the last follow-up.
Exclusion
- Any history or evidence of abnormal bleeding or coagulopathy; or evidence of prolonged or unexplained, clinically significant bleeding, or frequent unexplained bruising or thrombosis; or history of spontaneous bleeding;
- Evidence of active or suspected cancer within 3 years prior to screening (non-melanoma skin cancer, localized prostate cancer treated with curative intent, or other in situ carcinoma that does not require systemic therapy and is considered cured for at least 1 years is allowed);
- Acute febrile illness within 7 days prior to dose administration or evidence of active infection;
- Any major surgery within 3 months prior to screening or plan to have any major surgery during the study;
- History of clinically significant hypersensitivity, intolerance, or allergy to any oligonucleotide or GalNAc as determined by the investigator;
- Fasting TG≥ 500 mg/dL (5.6 mmol/L) during screening;
- Receipt of an investigational drug within 30 days or 5 half-lives of that drug, whichever is longer, prior to dose administration in this study;
- Have previously completed or withdrawn from this study or any other study investigating SRSD216 and have previously received SRSD216.
Key Trial Info
Start Date :
April 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT07172646
Start Date
April 7 2025
End Date
April 1 2027
Last Update
January 6 2026
Active Locations (1)
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1
Site 01
Beijing, Beijing Municipality, China, 100000