SRSD216 for people with high lipoprotein(a)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-part, randomized, placebo-controlled Phase 1/2 study that gives a single subcutaneous dose of SRSD216 to adults with elevated Lp(a). It will monitor safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) after dosing and identify dose ranges for later studies. The study may enroll participants with or without a history of atherosclerotic cardiovascular disease. All dosing and follow-up visits are conducted at the listed study site in Beijing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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* Have previously completed or withdrawn from this study or any other study investigating SRSD216 and have previously received SRSD216.

Where it's running

• Site 01
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Medical Director
• Email: medical@siriusrna.com
• Phone: +86 21 61207756

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• SRSD107 for people with chronic coronary or peripheral arterial disease

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  Recruiting Phase 2 Sirius Therapeutics Co., Ltd. · Beijing · NCT07318155

• Comparing SRSD107 and enoxaparin to prevent clots after total knee replacement

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  Recruiting Phase 2 Sirius Therapeutics Co., Ltd. · Nové Město na Moravě · NCT07140523

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.