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

NCT ID: NCT07172646

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-07
• Study Completion Date: 2027-04-30

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.

Conditions

Hyperlipoproteinemia (a)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

SRSD216 injection (Part 1)

SRSD216 administered SC. in subjects of Part 1

Group Type: EXPERIMENTAL

SRSD216 injection

Intervention Type: DRUG

Administered SC.

SRSD216 injection (Part 2)

SRSD216 administered SC. in subjects of Part 2

Group Type: EXPERIMENTAL

SRSD216 injection

Intervention Type: DRUG

Administered SC.

Placebo

Intervention Type: DRUG

Administered SC.

0.9% Sodium Chloride (Part 1)

Placbo administered SC. in subjects of Part 1

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Administered SC.

0.9% Sodium Chloride (Part 2)

Placbo administered SC. in subjects of Part 2

Group Type: PLACEBO_COMPARATOR

SRSD216 injection

Intervention Type: DRUG

Administered SC.

Placebo

Intervention Type: DRUG

Administered SC.

Interventions

SRSD216 injection

Administered SC.

Intervention Type: DRUG

Placebo

Administered SC.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sirius Therapeutics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director, MD

Role: STUDY_DIRECTOR

Sirius Therapeutics

Locations

Site 01

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Medical Director

Role: CONTACT

medical@siriusrna.com

+86 21 61207756

Facility Contacts

Investigator

Role: primary

medical@siriusrna.com

+86 21 61207756

Other Identifiers

SRSD216-101

Identifier Type: -

Identifier Source: org_study_id