Study on the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2004 Injection in Adult Patients With Atrial Fibrillation
NCT06280768 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2024-02-28
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
Interventions
- DRUG
-
SHR-2004 injection
dose 1 or dose 2 or dose 3 or dose 4 or dose 5 or dose 6
Sponsors & Collaborators
-
Beijing Suncadia Pharmaceuticals Co., Ltd
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 40 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-01
- Primary Completion
- 2024-12-31
- Completion
- 2024-12-31
More Related Trials
-
Comparing the Effects of Amiodarone, Sotalol, and Placebo in Maintaining Sinus Rhythm in Patients With Atrial Fibrillation Converted to Sinus Rhythm
NCT00007605 ·Status: COMPLETED ·Phase: PHASE3
-
Population Pharmacokinetics of Edoxaban in Chinese Patients With Non-Valvular Atrial Fibrillation
NCT05320627 ·Status: COMPLETED ·Phase: PHASE4
-
A Research Study on the Effects of NNC0537-1482 in Healthy Individuals When Injected Under the Skin
NCT06625307 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 2 Study of Oral K201 for Prevention of AF Recurrence
NCT01067833 ·Status: TERMINATED ·Phase: PHASE2
-
Efficacy and Safety of Sulcardine Sulfate Tablets in Patients With Premature Ventricular Contractions
NCT01235156 ·Status: UNKNOWN
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of APL180
NCT00907998 ·Status: COMPLETED ·Phase: PHASE1
-
Low-dose Versus Standard-dose Rivaroxaban in Elderly Patients With Atrial Fibrillation
NCT06108414 ·Status: RECRUITING ·Phase: PHASE4
-
Study of K201 Injection on Restoration of Sinus Rhythm in Subjects Who Are in Atrial Fibrillation
NCT00626652 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluation of the Efficacy and Safety of Nifekalant Hydrochloride (NIF) Injection.
NCT03855826 ·Status: UNKNOWN ·Phase: PHASE4
-
Safety and Effectiveness of Oral Anticoagulants in Patients With Non-valvular Atrial Fibrillation
NCT03570047 ·Status: COMPLETED
-
A Trial of Pharmacist Management of Oral Anticoagulation THerapy in the communitY for AF
NCT04907825 ·Status: COMPLETED ·Phase: PHASE4
-
A First Time in Human (FTIH) Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of GSK3884464 in Healthy Participants
NCT05044325 ·Status: TERMINATED ·Phase: PHASE1
-
A Study to Evaluate the Efficacy and Safety of Shenfu Zhusheye in Patients With Acute Heart Failure
NCT02135835 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Efficacy of APL180 in Healthy Volunteers and Patients With Coronary Heart Disease (CHD)
NCT00568594 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Trial of HRS-1893 in Patients With Obstructive Hypertrophic Cardiomyopathy
NCT06516068 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study of HRS-5632 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events
NCT07185776 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
NCT05724121 ·Status: RECRUITING
-
Evaluation of the Effect of Injectable Neucardin on Cardiac Function and Reversal Ventricular Remodeling in Patients With Chronic Systolic Heart Failure
NCT05949801 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase II Clinical Trial of HRS-1893 in the Treatment of Heart Failure With Preserved Ejection Fraction
NCT07269717 ·Status: RECRUITING ·Phase: PHASE2
-
DOAC in Chinese Patients With Atrial Fibrillation
NCT05378035 ·Status: RECRUITING
-
SGLT2i As Anti Arrhythmic Therapy to Prevent Sudden Cardiac Deaths.
NCT03366181 ·Status: COMPLETED
-
A Phase III Trial of HRS-1893 in Patients With Obstructive Hypertrophic Cardiomyopathy
NCT07021976 ·Status: RECRUITING ·Phase: PHASE3
-
Clinical Efficacy of Potassium Canrenoate in Sinus Rhythm Restoration Among Patients With Atrial Fibrillation.
NCT03536806 ·Status: UNKNOWN ·Phase: PHASE4
-
A Trial of HRS-1893 in Healthy Volunteers and Patients With Obstructive Hypertrophic Cardiomyopathy
NCT05879523 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy of Dapagliflozin on Recurrence After Catheter Ablation for Atrial Fibrillation
NCT06433479 ·Status: COMPLETED ·Phase: NA