drugset / Trial / NCT06162299
A Phase I, the Study to Evaluate the Safety, Immunogenicity and Efficacy of YS-HBV-002
NaParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2024-07-01
- Primary completion
- 2024-09-30
- Completion
- 2024-10-31
Outcome
Outcome not reported
Stopped (Business): “Business strategy”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | YS-HBV-002 | Vaccine | 0.5 ml | Intramuscular |
| Subject | YS-HBV-002 | Vaccine | 1 ml | Intramuscular |
| Subject | YS-HBV-002 | Vaccine | 2 ml | Intramuscular |