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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06280768
• Other study ID #: SHR-2004-102
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Beijing Suncadia Pharmaceuticals Co., Ltd
• Contact: Sheng Qi, M.D
• Phone: 0518-82342973
• Email: sheng.qi[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• SHR-2004 injection
dose 1 or dose 2 or dose 3 or dose 4 or dose 5 or dose 6

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Suncadia Pharmaceuticals Co., Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events (including bleeding events)		Up to 136 Days
Secondary	Pharmacokinetics of SHR2004: Peak Plasma Concentration (Cmax)		Up to 136 Days
Secondary	Pharmacokinetics of SHR2004: Area under the plasma concentration versus time curve (AUC)		Up to 136 Days
Secondary	Pharmacokinetics of Dupilumab: Elimination half life (t1/2)		Up to 136 Days
Secondary	PD endpoint: absolute and relative change values of coagulation factor XI (FXI) activity		Up to 136 Days
Secondary	PD endpoint: absolute and relative change values of activated partial thromboplastin time (APTT)		Up to 136 Days
Secondary	Immunogenicity endpoint: the incidence and timing of ADA positivity in SHR-2004		Up to 136 Days