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

NCT07655427 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-06-17

No results posted yet for this study

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.

Conditions

  • Thrombus

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.

Sponsors & Collaborators

  • Sirius Therapeutics Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Qiuyue Qu · Sirius Therapeutics Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07655427 on ClinicalTrials.gov