Atrial Fibrillation
Conditions
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.
Interventions
dose 1 or dose 2 or dose 3 or dose 4 or dose 5 or dose 6
Sponsors
Beijing Suncadia Pharmaceuticals Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events (including bleeding events) | Up to 136 Days |
Secondary
| 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 |
Countries
China
Outcome results
None listed