The primary aim of this study is to evaluate safety and tolerability data when SRSD107 is administered as single SC injections to healthy participants. This information, along with PK/PD data, will help establish the appropriate doses and dosing regimen for future studies in patients.
SRSD107 is a synthetic, chemically modified double-stranded, small interfering ribonucleic acid (siRNA). The antisense strand is specifically designed to recognize and cleave human factor XI (FXI) messenger ribonucleic acid (mRNA) which reduces FXI protein. FXI protein reduction may prevent thromboembolic events without increasing the risk of bleeding. This study will be a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study conducted in two parts. A total of 40 participants will be studied in 5 groups (Groups A1 to A5), each group consisting of 8 participants. In each group, 6 participants will receive SRSD107 and 2 will receive a placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
40
Linear Clinical Research
Perth, Other (Non U.s.), Australia
Proportion of adverse events (AEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Time frame: up to 168 days post last dose
Proportion of Serious Adverse Events (SAEs)
A serious AE (SAE) is defined as any untoward medical occurrence that at any dose either: * results in death * is life threatening * requires inpatient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity (disability is defined as a substantial disruption of a person's ability to conduct normal life functions) * results in a congenital anomaly/birth defect * results in an important medical event (see below).
Time frame: up to 168 days post last dose
Cmax
Maximum observed plasma concentration
Time frame: Group A, Day 1 to Day 3; Group B, Day 1 to Day 3 and Day 29 to 31
tmax
Time to maximum plasma concentration
Time frame: Group A, Day 1 to Day 3; Group B, Day 1 to Day 3 and Day 29 to 31
t1/2
Plasma half-life
Time frame: Group A, Day 1 to Day 3; Group B, Day 1 to Day 3 and Day 29 to 31
AUC
Area under the plasma concentration-time curve from 0 to infinity
Time frame: Group A, Day 1 to Day 3; Group B, Day 1 to Day 3 and Day 29 to 31
CL/F
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Apparent total clearance
Time frame: Group A, Day 1 to Day 3; Group B, Day 1 to Day 3 and Day 29 to 31
Effect of SRSD107 on circulating FXI Levels
Determination of % Lowering of FXI to Baseline FXI Level
Time frame: up to 168 days post last dose
Effect of SRSD107 on coagulation
Determination of % APTT to baseline APTT
Time frame: up to 168 days post last dose