Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06162299
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2023-11-22
Brief Title:
A Phase I The Study to Evaluate the Safety Immunogenicity and Efficacy of YS-HBV-002
Sponsor:
Yisheng Biopharma Singapore Pte Ltd
Organization:
Yisheng Biopharma Singapore Pte Ltd
Study Overview
Official Title:
A Phase I Double-blind Randomized Placebo-controlled Dose Escalating Study to Evaluate the Safety Immunogenicity and Efficacy of YS-HBV-002 in the Treatment of Chronic Hepatitis B CHB Infection in Adults 18 Years Old
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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 the first-in-human Phase I double-blind randomized placebo-controlled dose escalating study to evaluate the safety immunogenicity and preliminary efficacy of the YSHBV-002 in the treatment of CHB in adults 18 years old There will be 3 escalating doses of YS-HBV-002 to be administered intramuscularly 05mL 10mL and 20mL
Detailed Description:
This is the first-in-human Phase I double-blind randomized placebo-controlled dose escalating study to evaluate the safety immunogenicity and preliminary efficacy of the YSHBV-002 in the treatment of CHB in adults 18 years old There will be 3 escalating doses of YS-HBV-002 to be administered intramuscularly 05mL 10mL and 20mL Enrollment in the study will sequentially start from the low dose 05mL as Group A then to the mid-dose 10mL as Group B and lastly to the high dose of 20mL as Group C Each group will have 16 patients enrolled The first 4 enrollees in Group A will be sentinel patients and will be allocated at a 11 ratio to receive 05mL of either YS-HBV-002 or placebo Table 3 As there is no comparable equivalent to YS-HBV-002 available in the market the placebo of normal saline solution to be injected intramuscularly will serve as the control in this trial The next 12 enrollees in Group A will be the main patients and will be allocated at 51 to receive 05mL of either YS-HBV-002 or placebo The vaccination regimen will be 1 IM injection every 3 days in the deltoid muscle alternately for approximately 6 weeks A total of 14 injections will be administered to each patient
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?:
False
Is an FDA AA801 Violation?:
None