A Phase I/IIa, 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)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:
• 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.
Locations
Other Locations
China
Site 01
RECRUITING
Beijing
Contact Information
Primary
Medical Director
medical@siriusrna.com
+86 21 61207756
Time Frame
Start Date: 2025-04-07
Estimated Completion Date: 2027-04
Participants
Target number of participants: 48
Treatments
Experimental: SRSD216 injection (Part 1)
SRSD216 administered SC. in subjects of Part 1
Experimental: SRSD216 injection (Part 2)
SRSD216 administered SC. in subjects of Part 2
Experimental: 0.9% Sodium Chloride (Part 1)
Placbo administered SC. in subjects of Part 1
Placebo_comparator: 0.9% Sodium Chloride (Part 2)
Placbo administered SC. in subjects of Part 2
Related Therapeutic Areas
Sponsors
Leads: Sirius Therapeutics Co., Ltd.