Thrombosis Clinical Trial
Official title:
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered SRSD107 in Healthy Participants
The primary objective of this study is to evaluate safety and tolerability data when SRSD107 is administered as single and multiple 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 designed to specifically recognize and cleave human factor XI (FXI) messenger ribonucleic acid (mRNA) which reduces FXI protein. FXI protein reduction may prevent thromboembolic events without increasing bleeding risk. This study will be a phase 1, randomized, double blind, placebo controlled, single and multiple ascending dose study conducted in two parts. Part A will comprise a single dose, sequential group design. A total of 40 participants will be studied in 5 groups (Groups A1 to A5), with each group comprising 8 participants. In each group, 6 participants will receive SRSD107 and 2 participants will receive placebo. Part B will comprise a multiple dose, sequential group design. A total of 24 participants will be studied in 3 groups (Groups B1 to B3), with each group comprising 8 participants. In each group, 6 participants will receive SRSD107 and 2 participants will receive placebo. ;
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