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Completed

NCT Number: NCT06280768

Study on the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2004 Injection in Adult 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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The second Affiliated Hospital Zhejiang University School of Mdeicine

Hangzhou, Zhejiang, 310009, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

SHR-2004 injection

Drug

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

Primary outcomes

  1. Incidence and severity of adverse events (including bleeding events)

    Time frame: Up to 136 Days

Secondary outcomes

  1. Pharmacokinetics of SHR2004: Peak Plasma Concentration (Cmax)

    Time frame: Up to 136 Days

  2. Pharmacokinetics of SHR2004: Area under the plasma concentration versus time curve (AUC)

    Time frame: Up to 136 Days

  3. Pharmacokinetics of Dupilumab: Elimination half life (t1/2)

    Time frame: Up to 136 Days

  4. PD endpoint: absolute and relative change values of coagulation factor XI (FXI) activity

    Time frame: Up to 136 Days

  5. PD endpoint: absolute and relative change values of activated partial thromboplastin time (APTT)

    Time frame: Up to 136 Days

  6. Immunogenicity endpoint: the incidence and timing of ADA positivity in SHR-2004

    Time frame: Up to 136 Days

Sponsors and collaborators

Lead sponsor

Beijing Suncadia Pharmaceuticals Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2024
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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