NCT06162299

A Phase I, the Study to Evaluate the Safety, Immunogenicity and Efficacy of YS-HBV-002

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: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Yisheng Biopharma (Singapore) Pte. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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: 0.5mL, 1.0mL, and 2.0mL.

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: 0.5mL, 1.0mL, and 2.0mL. Enrollment in the study will sequentially start from the low dose 0.5mL as Group A, then to the mid-dose 1.0mL as Group B and lastly to the high dose of 2.0mL 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 1:1 ratio to receive 0.5mL 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 5:1 to receive 0.5mL 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.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	YS-HBV-002	YS-HBV-002, A recombinant hepatitis B vaccine with PIKA adjuvant

Timeline

• Start date: 2024-07-01
• Primary completion: 2024-09-30
• Completion: 2024-10-31
• First posted: 2023-12-08
• Last updated: 2025-02-24

Locations

1 site across 1 country: Philippines