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NCT05856890 · ClinicalTrials.gov registry record · Phase 1
HepB mAb19 in Individuals With Chronic Hepatitis B Infection
A Phase 1 study of Hepatitis B and Hepatitis b Virus, sponsored by Rockefeller University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 2
- Study locations
NCT05856890: Recruiting Phase 1 study of Hepatitis B and Hepatitis b Virus, sponsored by Rockefeller University.
NCT05856890 is a Phase 1 study of Hepatitis B and Hepatitis b Virus that is actively recruiting participants, run by Rockefeller University. The registered enrollment target is 37 participants, below the 1,627-participant average among 32 other Hepatitis B trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05856890, a Phase 1 study of Hepatitis B and Hepatitis b Virus, is actively recruiting participants, sponsored by Rockefeller University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a first-in-human, placebo-controlled, single dose, dose-escalation phase 1 study to evaluate the safety, pharmacokinetics and antiviral activity of a highly potent neutralizing anti-HBV monoclonal antibody (mAb), HepB mAb19, which targets the S-protein in individuals with chronic hepatitis B (CHB) on nucleos(t)ide analog therapy (NRTI).
Primary Outcome
The occurrence of solicited AEs will be assessed 2 weeks after IP administration.
Conditions Studied
Interventions
- BIOLOGICAL HepB mAb19
- OTHER Sterile Saline
Study Locations (2)
New York
- NYU Langone Health - New York
- The Rockefeller University - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2023-08-07 |
| Est. Completion | 2028-03-30 |
| Phase | Phase 1 |
What NCT05856890 shows while recruiting
NCT05856890 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 1,627-participant average among 32 other Hepatitis B trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Hepatitis B appearing as the primary indexed condition, and to 2 interventions - of which HepB mAb19 is the first listed.
NCT05856890 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05856890 about?
NCT05856890 is a clinical study titled "HepB mAb19 in Individuals With Chronic Hepatitis B Infection". This is a first-in-human, placebo-controlled, single dose, dose-escalation phase 1 study to evaluate the safety, pharmacokinetics and antiviral activity of a highly potent neutralizing anti-HBV monoclonal antibody (mAb), HepB mAb19, which targets the S-protein in individuals with chronic hepatitis B...
What is the current status of trial NCT05856890?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2023-08-07. Estimated completion is 2028-03-30.
What conditions does trial NCT05856890 study?
This clinical trial studies the following conditions: Hepatitis B, Hepatitis b Virus.
What interventions are being tested in trial NCT05856890?
The interventions under investigation include: HepB mAb19 (BIOLOGICAL), Sterile Saline (OTHER).
Who is sponsoring clinical trial NCT05856890?
This trial is sponsored by Rockefeller University, which has 117 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05856890 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatitis B
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05856890's enrollment target sits among peer trials
37 23rd of 32 higher than 10 of 32 other Hepatitis B trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatitis B trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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