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COMPLETED
NCT07655427
PHASE1

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

Sponsor: Sirius Therapeutics Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered SRSD107 in Healthy Subjects

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2024-03-29

Completion Date

2025-03-02

Last Updated

2026-06-17

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

SRSD107

SRSD107 is a synthetic, chemically modified double-stranded siRNA designed to silence hepatic FXI mRNA, thereby modulating coagulation.

DRUG

Placebo

Sodium chloride for subcutaneous injection.

Locations (1)

Beijing Tiantan Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China