A Study to Evaluate SGB-3403 in Healthy Volunteers - Trial ANZCTR12623000439640

Timeline & Enrollment

Primary Outcome

Safety and tolerability will be assessed by the incidence of adverse events assessed by triplicate 12-lead ECG (heart rate, PR interval, QRS interval, HR, QT, and QTc interval), physical examination (includes, at a minimum head, eyes, ears, nose, throat, neck, and lymph nodes, and the cardiovascular, dermatological, musculoskeletal, respiratory, gastrointestinal, and neurological systems), vital signs assessed by vital signs monitor (vital signs monitor can simultaneously monitor blood pressure, heart rate, respiratory rate, and temperature), blood monitoring and by collection of a blood sample for assessment of chemistry and hematology, serology (HIV, HBsAg, HBV, Syphilis, and HCV), coagulation and urine sample for urinalysis. Adverse effects will be coded using the latest version of MedDRA, summaries will be based on treatment-emergent adverse events and will be evaluated and documented using NCI-CTCAE-V5.0 and Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA 2007). The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline.

Summary

This is a Randomized, Double-blind, Placebo-controlled, Single Ascending Dose (SAD) Study evaluating the safety, tolerability, Pharmacokinetics and Pharmacodynamics of SGB-3403 subcutaneously administered in Healthy Subjects. The primary purpose of this study is to evaluate the safety and tolerability of SGB-3403 when administered subcutaneously as a single ascending dose in healthy volunteers. The secondary purpose of this study is to characterize and evaluate the pharmacokinetics and pharmacodynamic effect of SGB-3403 following subcutaneous administration. The SAD phase will enroll 37 healthy participants to be split into 5 cohorts. Cohort 1 will comprise 5 subjects (3 active, 2 placeboes) whilst the remaining 4 cohorts of the SAD phase will consist of 8 participants (6 active, 2 placeboes). Single doses of 30, 100, 300, 500, and 800 mg of SBG-3403 administered subcutaneously will be evaluated. Participants will complete a total of 3 overnight stays [admission on D-1 to post-dose on D3, followed by 9 follow-up visits on Day 5, Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, and Day 85, then every 4 weeks until LDL-C level returns to = 80% of baseline, but not exceed 180 days after the last study drug administration.. Each cohort commences only if previously collected data, including PK data (if available), does not highlight safety concerns after consultation with the Safety Review Committee (SRC). Following the starting dose of SGB-3403, decisions regarding dose escalation will be based on safety and tolerability assessments, PK data (if available), and reviewed SRC. Safety assessments will include monitoring of Adverse Events (AEs), vital signs (blood pressure, pulse rate, respiratory rate, and body temperature), clinical laboratory findings, 12-lead electrocardiograms (ECGs), and physical examination.

ICD-10 Classifications