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Study on the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2004 Injection in Adult Patients With Atrial Fibrillation - Trial NCT06280768

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.

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NCT06280768
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06280768
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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

Study Focus

Atrial Fibrillation

SHR-2004 injection

Interventional

drug

Sponsor & Location

Beijing Suncadia Pharmaceuticals Co., Ltd

Timeline & Enrollment

Phase 1

Mar 01, 2024

Dec 31, 2024

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 fibrillation
Persistent atrial fibrillation
Paroxysmal atrial fibrillation
Atrial fibrillation and flutter
Atrial fibrillation and atrial flutter, unspecified

Data Source

ClinicalTrials.gov

NCT06280768

Non-Device Trial