Hyperlipoproteinemia (a)
Conditions
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 elevated Lp(a) level with or without ASCVD history.
Interventions
DRUGSRSD216 injection
Administered SC.
DRUGPlacebo
Administered SC.
Sponsors
Sirius Therapeutics Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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of that drug, whichever is longer, prior to dose administration in this study; * Have previously completed or withdrawn from this study or any other study investigating SRSD216 and have previously received SRSD216.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | 1 year | A summary of TEAE to evaluate the safety and tolerability of SRSD216 |
Countries
China
Contacts
Primary ContactMedical Director
Outcome results
None listed