NCT06280768CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- First submitted
- 20 Feb 2024
- Start date
- 10 Apr 2024
- Primary completion date
- 10 Jan 2025
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., Ltd
- Diseases
- Atrial fibrillation
- NCT number
- NCT06280768
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 10
- From 10 Apr 2024 to the primary completion date, 10 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- Patients with a mechanical heart valve;
- 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;
Other
- Rheumatic mitral stenosis or moderate to severe non-rheumatic mitral stenosis;
- Females who are pregnant or lactating.
Who the study is looking for
- 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.
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The second Affiliated Hospital Zhejiang University School of Mdeicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.