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

NCT06162299 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-02-24

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

YS-HBV-002

YS-HBV-002, A recombinant hepatitis B vaccine with PIKA adjuvant

Sponsors & Collaborators

  • Yisheng Biopharma (Singapore) Pte. Ltd.

    lead INDUSTRY

Principal Investigators

  • Ike Minerva, MD · Iloilo Doctors' Hospiyal

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2024-09-30
Completion
2024-10-31

Countries

  • Philippines

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06162299 on ClinicalTrials.gov