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

NCT ID: NCT06280768

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-12-31

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR-2004 injection

Group Type: EXPERIMENTAL

SHR-2004 injection

Intervention Type: DRUG

dose 1 or dose 2 or dose 3 or dose 4 or dose 5 or dose 6

Interventions

SHR-2004 injection

dose 1 or dose 2 or dose 3 or dose 4 or dose 5 or dose 6

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Suncadia Pharmaceuticals Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Sheng Qi, M.D

Role: CONTACT

sheng.qi@hengrui.com

0518-82342973

Other Identifiers

SHR-2004-102

Identifier Type: -

Identifier Source: org_study_id