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
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
Treatments tested in this trial
- SRSD216 injection
- Placebo
Treatment groups
84 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov