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

NCT06280768 | Not Yet Recruiting Phase 1

• 1 other identifier: SHR-2004-102
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events (including bleeding events)

  Up to 136 Days

Secondary Outcomes (6)

• 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

Study Arms (1)

SHR-2004 injection

EXPERIMENTAL

Drug: SHR-2004 injection

Interventions

SHR-2004 injection DRUG

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

SHR-2004 injection

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Suncadia Pharmaceuticals Co., Ltd: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sheng Qi, M.D

CONTACT

0518-82342973; sheng.qi@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: March 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02