Recruiting
Phase 1/2
A Study of SRSD216 in Patients With Elevated Lipoprotein (a)
Condition(s) studied
Hyperlipoproteinemia (a)
Investigational drug(s) / intervention(s)
SRSD216 injectionPlacebo
SRSD216 injection: Administered SC.
Placebo: Administered SC.
Study 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 elevated Lp(a) level with or without ASCVD history.
Eligibility
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* Have previously completed or withdrawn from this study or any other study investigating SRSD216 and have previously received SRSD216.
Primary outcome measure(s)
- Incidence of treatment-emergent adverse events (TEAEs) — 1 year
A summary of TEAE to evaluate the safety and tolerability of SRSD216
Trial sites (1)
| Facility | City | Region | Status |
| Site 01 |
Beijing |
Beijing Municipality |
Recruiting |
More Sirius Therapeutics Co., Ltd. trials in China
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