A Study of SRSD216 in Patients With Elevated Lipoprotein (a)
Recruiting
Phase 1Phase 2Interventional Study
Hyperlipoproteinemia (a)
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
84 (estimated)
Sponsor
Sirius Therapeutics Co., Ltd. · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 a…
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.