Sirnaomics Ltd (HKG: 2257) has announced the first systemic dosing of a Phase I clinical trial for its leading RNAi drug candidate, STP122G, an anticoagulation treatment. STP122G, developed using Sirnaomics’ GalNAc RNAi delivery platform technology GalAhead, targets Factor XI and has broad applicability across various disease indications, including the potential prevention and treatment of stroke after atrial fibrillation, support for cancer patients post-immunotherapy, and enhancement of recovery following total knee replacement.
Design and Objectives of the Phase I Study
The Phase I study is a single-center, randomized, double-blind, and sequential cohort trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single ascending dose of STP122G when administered subcutaneously to healthy participants. The trial will compare the safety and tolerability among five different doses of STP122G (25 mg, 50 mg, 100 mg, 200 mg, 400 mg) to select the most appropriate dose for future studies. The study plans to recruit a total of 40 participants.
Significance of the Trial and Future Prospects
This trial marks a significant step in the development of STP122G, which has the potential to revolutionize anticoagulant therapy. The data generated from this study will be crucial in determining the safety profile and optimal dosing strategy for STP122G, paving the way for further clinical development and potentially transforming the treatment landscape for various conditions requiring anticoagulant intervention.-Fineline Info & Tech