Study on the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2004 Injection in Adult Patients With Atrial Fibrillation

Phase 1

Not yet recruiting

• Conditions: Atrial Fibrillation
• Interventions: Drug: SHR-2004 injection

• Registration Number: NCT06280768
• Lead Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-20
• Study First Submitted QC: 2024-02-20
• Last Update Submitted: 2024-02-20
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28
• Study Start: 2024-03-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing;
2. Male or female ≥ 40 years and < 80 years old；
3. 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

1. Patients with a mechanical heart valve;
2. Rheumatic mitral stenosis or moderate to severe non-rheumatic mitral stenosis;
3. 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;
4. Concomitant poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100mmHg) at screening;
5. Those who are allergic to the trial drug or any component of the trial drug;
6. 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;
7. Females who are pregnant or lactating.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR-2004 injection	SHR-2004 injection	-

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events (including bleeding events)	Up to 136 Days

Secondary Outcome Measures

Name	Time	Method
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