A Study of SRSD216 in Patients With Elevated Lipoprotein (a)
A Phase I/II, Randomized, Double Blind, Placebo Controlled, Dose-Escalation and -Expansion Study to Evaluate the Safety, Tolerability, PK, and PD of Subcutaneously Administered SRSD216 in Patients With Elevated Lipoprotein(a)
Sirius Therapeutics Co., Ltd.
84 participants
Apr 7, 2025
INTERVENTIONAL
Conditions
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 Criteria4
- 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 Criteria8
- 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- Have previously completed or withdrawn from this study or any other study investigating SRSD216 and have previously received SRSD216.
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Interventions
Administered SC.
Administered SC.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07172646