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drugset / Trial / NCT06116617

A Phase 1 Study to Evaluate the Safety, Tolerability, PK/PD of SRSD107 in Healthy Participants

NCT06116617 ↗

Phase 1 Completed 40 enrolled Sirius Therapeutics Co., Ltd.
RandomizedParallel-groupQuadruple-blindPrevention

Summary

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.

Timeline

Start
2024-01-23
Primary completion
2024-12-09
Completion
2025-04-30

Drugs

EvaluationDrugModalityDoseRoute
Subject SRSD107 Small interfering RNA (siRNA) 15 mg Subcutaneous
Subject SRSD107 Small interfering RNA (siRNA) 45 mg Subcutaneous
Subject SRSD107 Small interfering RNA (siRNA) 120 mg Subcutaneous
Subject SRSD107 Small interfering RNA (siRNA) 240 mg Subcutaneous
Subject SRSD107 Small interfering RNA (siRNA) 450 mg Subcutaneous

Indications

thrombotic disease