Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 11:33 PM
Study NCT ID:
NCT06115993
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-25
First Post:
2023-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Efficacy of AHB-137 in Healthy Participants and HBeAg-negative Chronic Hepatitis B (CHB) Patients
Sponsor:
Ausper Biopharma Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase I/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Single Ascending Doses and Multiple Doses of AHB-137 in Healthy Participants and HBeAg-negative CHB Patients Receiving Stable Nucleos(t)Ide Analogues (NAs) Treatment
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-04
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:
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of AHB-137 subcutaneous injection in healthy participants after single and multiple doses, and evaluate the preliminary efficacy of AHB-137 in CHB participants after up to 24 weeks of treatment as a proof-of-concept.
Detailed Description:
This study is a three-part study of AHB-137, including Part Ia, Part Ib and Part IIa. Part Ia evaluates the safety, tolerability, pharmacokinetics of AHB-137 following single-ascending doses (SAD) and multiple-ascending doses (MAD) in healthy participants. Part Ib is a multiple-dose study to assess the safety, tolerability, pharmacokinetics, and initial efficacy of AHB-137 in CHB participants following weekly dosing for 4 weeks with two loading doses in the first two weeks. Part IIa is a multiple-dose study to evaluate the preliminary efficacy, safety and pharmacokinetics of AHB-137 in CHB participants following weekly dosing for 24 weeks with two loading doses in the first two weeks.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: