drugset / Trial / NCT07655427

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SRSD107 in Healthy Chinese Subjects

NCT07655427

Phase 1 Completed 48 enrolled Sirius Therapeutics Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This was a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneously administered SRSD107 in Chinese healthy subjects. SRSD107 is a synthetic, chemically modified double-stranded siRNA designed to silence hepatic FXI mRNA, thereby modulating coagulation.

Timeline

Start
2024-03-29
Primary completion
2025-03-02
Completion
2025-03-02

Drugs

EvaluationDrugModalityDoseRoute
Subject SRSD107 Small interfering RNA (siRNA) Subcutaneous

Indications