Atrial FibrillationPhase 1NCT06280768
Study on the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2004 Injection in Adult Patients With Atrial Fibrillation
A Phase 1 study testing SHR-2004 injection in people with Atrial Fibrillation, run by Beijing Suncadia Pharmaceuticals Co., Ltd at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- SHR-2004 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2024to 10 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The second Affiliated Hospital Zhejiang University School of Mdeicine
Hangzhou, Zhejiang, 310009
About this study
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
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
- Being tested
- SHR-2004 injection
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-2004 injectionDrug
dose 1 or dose 2 or dose 3 or dose 4 or dose 5 or dose 6
| Study group | Role | What they receive |
|---|---|---|
| SHR-2004 injection | Experimental | Not described Receives: Drug: SHR-2004 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (including bleeding events)
Measured: Up to 136 Days
Secondary outcomes (6)
Pharmacokinetics of SHR2004: Peak Plasma Concentration (Cmax)
Measured: Up to 136 Days
Pharmacokinetics of SHR2004: Area under the plasma concentration versus time curve (AUC)
Measured: Up to 136 Days
Pharmacokinetics of Dupilumab: Elimination half life (t1/2)
Measured: Up to 136 Days
PD endpoint: absolute and relative change values of coagulation factor XI (FXI) activity
Measured: Up to 136 Days
PD endpoint: absolute and relative change values of activated partial thromboplastin time (APTT)
Measured: Up to 136 Days
Immunogenicity endpoint: the incidence and timing of ADA positivity in SHR-2004
Measured: Up to 136 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start10 Apr 2024
- Primary completion10 Jan 2025
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Beijing Suncadia Pharmaceuticals Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280768
- Sponsor's protocol ID
- SHR-2004-102
- Status last verified
- Aug 2026
- First submitted
- 20 Feb 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jiang J, Wang Y, Zhang Y, Zhang P, Wu J, Lin Y, Su G, Wen Q, Ye J, Dong Y, Wang Y, Wang J. Safety, Pharmacokinetics, and Pharmacodynamics of SHR-2004, a Novel Humanized Monoclonal Antibody Targeting Factor XI, in Patients with Atrial Fibrillation: An Open-Label Phase 1b Study. Clin Pharmacokinet. 2026 Oct 30. doi: 10.1007/s40262-026-01720-7. Online ahead of print.
PubMed 42961609
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06280768
- Acronym / sponsor ID
- SHR-2004-102
- Conditions
- Atrial Fibrillation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Beijing Suncadia Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-2004 injection | Experimental | Drug: SHR-2004 injection |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-2004 injectiondose 1 or dose 2 or dose 3 or dose 4 or dose 5 or dose 6 | Drug | SHR-2004 injection |
Primary outcome
Incidence and severity of adverse events (including bleeding events)
Time frame: Up to 136 Days
6 secondary outcomes
Pharmacokinetics of SHR2004: Peak Plasma Concentration (Cmax)
Time frame: Up to 136 Days
Pharmacokinetics of SHR2004: Area under the plasma concentration versus time curve (AUC)
Time frame: Up to 136 Days
Pharmacokinetics of Dupilumab: Elimination half life (t1/2)
Time frame: Up to 136 Days
PD endpoint: absolute and relative change values of coagulation factor XI (FXI) activity
Time frame: Up to 136 Days
PD endpoint: absolute and relative change values of activated partial thromboplastin time (APTT)
Time frame: Up to 136 Days
Immunogenicity endpoint: the incidence and timing of ADA positivity in SHR-2004
Time frame: Up to 136 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Derived from this study: PubMed 42961609Jiang J, Wang Y, Zhang Y, Zhang P, Wu J, Lin Y, Su G, Wen Q, Ye J, Dong Y, Wang Y, Wang J. Safety, Pharmacokinetics, and Pharmacodynamics of SHR-2004, a Novel Humanized Monoclonal Antibody Targeting Factor XI, in Patients with Atrial Fibrillation: An Open-Label Phase 1b Study. Clin Pharmacokinet. 2026 Oct 30. doi: 10.1007/s40262-026-01720-7. Online ahead of print.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR-2004 injection in people with Atrial Fibrillation, run by Beijing Suncadia Pharmaceuticals Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (including bleeding events) (time frame: Up to 136 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06280768, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.