A Study of SRSD216 in Patients With Elevated Lipoprotein (a)

Sirius Therapeutics

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Hyperlipoproteinemia (a)

Treatments: Drug: SRSD216 injection; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07172646

SRSD216-101

Details and patient eligibility

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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• Have previously completed or withdrawn from this study or any other study investigating SRSD216 and have previously received SRSD216.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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84 participants in 4 patient groups, including a placebo group

SRSD216 injection (Part 1)

Experimental group

Description:

SRSD216 administered SC. in subjects of Part 1

Treatment:

Drug: SRSD216 injection

SRSD216 injection (Part 2)

Experimental group

Description:

SRSD216 administered SC. in subjects of Part 2

Treatment:

Drug: Placebo

Drug: SRSD216 injection

0.9% Sodium Chloride (Part 1)

Experimental group

Description:

Placbo administered SC. in subjects of Part 1

Treatment:

Drug: Placebo

0.9% Sodium Chloride (Part 2)

Placebo Comparator group

Description:

Placbo administered SC. in subjects of Part 2

Treatment:

Drug: Placebo

Drug: SRSD216 injection