Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452693
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-06-06
Brief Title:
A Clinical Study to Evaluate the Efficacy of TQA3038 Injection in Patients With Chronic Hepatitis B
Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co Ltd
Organization:
Chia Tai Tianqing Pharmaceutical Group Co Ltd
Study Overview
Official Title:
A Phase IbIIa Clinical Trial to Evaluate the Safety Tolerability Pharmacokinetic and Antiviral Efficacy of TQA3038 Injection in Patients With Chronic Hepatitis B
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is divided into two parts Phase Ib is a randomized double-blind placebo-controlled trial designed to evaluate the safety tolerability pharmacokinetic characteristics preliminary efficacy and immunogenicity of TQA3038 injection in patients with chronic hepatitis B It is expected to include 72 subjects Phase IIa adopted an open-label randomized parallel-controlled design with a total of 90 subjects included mainly evaluating the changes in serum HBsAg compared to baseline at the end of the 48th week
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None