New antibody therapy targeting hepatitis B surface protein
First-in-human study of a potent anti-HBsAg neutralizing antibody
Testing a lab-made antibody medicine that targets the hepatitis B surface protein to help people with chronic hepatitis B.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Rockefeller University NIH-funded |
| Lab location | 1 site (New York, United States) |
| Project ID | NIH-11302637 on NIH RePORTER |
What this research studies
You would receive a human monoclonal antibody (HepB mAb19) designed to bind the hepatitis B surface antigen (HBsAg) and help clear virus and infected cells. The team will give one or more infusions and monitor blood for HBsAg, viral load, immune responses, and liver safety over several months. This antibody showed very strong neutralizing activity in laboratory tests and reduced virus in animal models, and this first-in-human effort will look at how it works and how safe it is in people. Participation involves clinic visits, blood draws, and liver monitoring while researchers track immune changes and any side effects.
Who could benefit from this research
Good fit: Adults with chronic hepatitis B who have measurable HBsAg and meet the study's safety criteria would be the ideal candidates.
Not a fit: People without chronic hepatitis B (for example, those only vaccinated) or those with severe liver failure or other uncontrolled serious illnesses are unlikely to benefit.
Why it matters
Potential benefit: If successful, this antibody could lower HBsAg levels, strengthen your immune control of HBV, and potentially allow long-term virus suppression without continuous antiviral drugs.
How similar studies have performed: Monoclonal antibody treatments have been effective for other viruses and this antibody showed strong lab and animal results, but first-in-human use for chronic HBV is novel.
Where this research is happening
New York, United States
- Rockefeller University — New York, United States (Active)
Researchers
- Principal investigator: Caskey, Marina — Rockefeller University
- Study coordinator: Caskey, Marina
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.