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NCT Number: NCT07172646

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

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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • Have previously completed or withdrawn from this study or any other study investigating SRSD216 and have previously received SRSD216.

Treatment and study plan

SRSD216 injection

Drug

Administered SC.

Placebo

Drug

Administered SC.

Primary outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: 1 year

    A summary of TEAE to evaluate the safety and tolerability of SRSD216

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Director

CONTACT

[email protected]

+86 21 61207756

Sponsors and collaborators

Lead sponsor

Sirius Therapeutics Co., Ltd.

Industry

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 15, 2025
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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