A Phase Ib Clinical Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of SHR-2004 Injection in Patients With Atrial Fibrillation

Beijing Suncadia Pharmaceuticals Co., Ltd0 sites48 target enrollmentMarch 1, 2024

ConditionsAtrial Fibrillation

InterventionsSHR-2004 injection

DrugsSHR-2004 injection

Overview

Phase: Phase 1
Intervention: SHR-2004 injection
Conditions: Atrial Fibrillation
Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd
Enrollment: 48
Primary Endpoint: Incidence and severity of adverse events (including bleeding events)
Status: Not Yet Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This study is an open-label Phase Ib clinical study with the primary objective of evaluating the safety and tolerability of multiple subcutaneous injections of SHR-2004 injection in patients with atrial fibrillation, and the secondary objective is to evaluate its pharmacokinetic (PK), pharmacodynamic (PD) and immunogenicity characteristics.

Registry

clinicaltrials.gov

Start Date

March 1, 2024

End Date

December 31, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Beijing Suncadia Pharmaceuticals Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing;
•Male or female ≥ 40 years and \< 80 years old；
•History of atrial fibrillation or atrial flutter, or newly diagnosed atrial fibrillation or atrial flutter during the screening period, as documented by Holter ECG or 12-lead ECG at the time of screening or within 12 months prior to screening.

Exclusion Criteria

•Patients with a mechanical heart valve;
•Rheumatic mitral stenosis or moderate to severe non-rheumatic mitral stenosis;
•Atrial fibrillation or atrial flutter is caused by reversible causes, or successful ablation has been converted to sinus rhythm, or cardioversion or ablation surgery is planned during the study;
•Concomitant poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100mmHg) at screening;
•Those who are allergic to the trial drug or any component of the trial drug;
•Unstable or severe liver, renal, cardiovascular, psychiatric, neurological, endocrine, hematological and other diseases at the time of screening, and the investigator judges that it is not suitable to participate in the study;
•Females who are pregnant or lactating.

Arms & Interventions

SHR-2004 injection

Intervention: SHR-2004 injection

Outcomes

Primary Outcomes

Incidence and severity of adverse events (including bleeding events)

Time Frame: Up to 136 Days

Secondary Outcomes

Pharmacokinetics of Dupilumab: Elimination half life (t1/2)(Up to 136 Days)
Pharmacokinetics of SHR2004: Area under the plasma concentration versus time curve (AUC)(Up to 136 Days)
Pharmacokinetics of SHR2004: Peak Plasma Concentration (Cmax)(Up to 136 Days)
PD endpoint: absolute and relative change values of coagulation factor XI (FXI) activity(Up to 136 Days)
PD endpoint: absolute and relative change values of activated partial thromboplastin time (APTT)(Up to 136 Days)
Immunogenicity endpoint: the incidence and timing of ADA positivity in SHR-2004(Up to 136 Days)