Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06384131
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-22
Brief Title:
A Study to Assess the Safety Pharmacokinetics and Antiviral Activity of ABI-4334 in Subjects With Chronic Hepatitis B Virus Infection
Sponsor:
Assembly Biosciences
Organization:
Assembly Biosciences
Study Overview
Official Title:
A Randomized Blinded Placebo-Controlled Dose-Ranging Phase 1b Study of the Safety Pharmacokinetics and Antiviral Activity of ABI-4334 in Subjects With Chronic Hepatitis B Virus Infection
Status:
RECRUITING
Status Verified Date:
2024-09
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 is a randomized blinded placebo-controlled dose-ranging Phase 1b study of the safety PK and antiviral activity of ABI-4334 in treatment-naïve or off-treatment chronic Hepatitis B virus cHBV subjects that are Hepatitis B e antigen HBeAg positive or negative The study will enroll up to 5 sequential cohorts of 10 subjects each for a total of up to 50 subjects randomized 82 to receive ABI-4334 or placebo
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-511051-18 | EUDRACT_NUMBER | None | None |