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

ConditionHyperlipoproteinemia (a)

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18-70

SponsorSirius Therapeutics Co., Ltd.

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

SRSD216 injection
Drug
Administered SC.
Placebo
Drug
Administered SC.

Treatment groups

84 Participants

are divided into 4 treatment groups

Group A: SRSD216 injection (Part 1)Experimental treatment 1 intervention

Group B: SRSD216 injection (Part 2)Experimental treatment 2 interventions

Group C: 0.9% Sodium Chloride (Part 1)Experimental treatment 1 intervention

Group D: 0.9% Sodium Chloride (Part 2)Placebo comparator 2 interventions

Trial outcomes

Primary outcomes

Incidence of treatment-emergent adverse events (TEAEs)

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

Time frame

1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sirius Therapeutics Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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