BridgeMD
New treatment option for Hyperlipoproteinemia (a)
Official title A Study of SRSD216 in Patients With Elevated Lipoprotein (a)
ClinicalTrials.gov ID: NCT07172646
What this study is testing
What is SRSD216 injection?
SRSD216 injection is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hyperlipoproteinemia (a).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- 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 people are not allowed to donate sperm, and female people are not allowed to donate eggs from the time the ICF is signed until at least 3 months...
You likely can't join if
- Any history or evidence of abnormal bleeding or coagulopathy; or evidence of prolonged or unexplained, clinically significant bleeding, or frequent...
- Evidence of active or suspected cancer within 3 years prior to screening (non-melanoma skin cancer, localized prostate cancer treated with curative...
- 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;
See the full eligibility 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 people are not allowed to donate sperm, and female people are not allowed to donate eggs from the time the ICF is signed until at least 3 months after the last follow-up.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.