Pure Global AI
NCT06280768Not yet recruiting

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
Beijing Suncadia Pharmaceuticals Co., LtdPhase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Atrial Fibrillation
Drug/Device/Intervention
SHR-2004 injection
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Beijing Suncadia Pharmaceuticals Co., Ltd
Timeline & enrollment
Phase
Phase 1
Start date
Mar 01, 2024
End date
Dec 31, 2024
Enrollment
48 participants
Primary outcome

Incidence and severity of adverse events (including bleeding events)

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.

ICD-10 classifications
Chronic atrial fibrillationPersistent atrial fibrillationParoxysmal atrial fibrillationAtrial fibrillation and flutterAtrial fibrillation and atrial flutter, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06280768
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06280768 through Pure Global AI's free database. This Phase 1 trial is sponsored by Beijing Suncadia Pharmaceuticals Co., Ltd and is currently Not yet recruiting. The study focuses on Atrial Fibrillation. Target enrollment is 48 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.