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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: SHR-2004 injection

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Sheng Qi, M.D; Phone Number: 0518-82342973; Email: sheng.qi@hengrui.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-2004 injection	Drug: SHR-2004 injection; dose 1 or dose 2 or dose 3 or dose 4 or dose 5 or dose 6

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of adverse events (including bleeding events)	Up to 136 Days

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics of SHR2004: Peak Plasma Concentration (Cmax)	Up to 136 Days
Pharmacokinetics of SHR2004: Area under the plasma concentration versus time curve (AUC)	Up to 136 Days
Pharmacokinetics of Dupilumab: Elimination half life (t1/2)	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

Collaborators and Investigators

• Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Estimated): February 28, 2024

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: SHR-2004-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No