Actively Recruiting
A Study of SRSD216 in Patients With Elevated Lipoprotein (a)
Led by Sirius Therapeutics Co., Ltd. · Updated on 2026-01-06
84
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 elevated Lp(a) level with or without ASCVD history.
CONDITIONS
Official Title
A Study of SRSD216 in Patients With Elevated Lipoprotein (a)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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 triglycerides ≥ 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- Have previously completed or withdrawn from this study or any other study investigating SRSD216 and have previously received SRSD216
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Site 01
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
M
Medical Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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