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Monoclonal Antibodies

HepB mAb19 for Chronic Hepatitis B

Phase 1
Recruiting
Led By Marina Caskey, MD
Research Sponsored by Rockefeller University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks

Summary

This trial tests the safety & effectiveness of a new antibody-based drug to treat chronic hepatitis B in people already on medication.

Who is the study for?
Adults aged 18-70 with chronic Hepatitis B on nucleos(t)ide therapy for at least 6 months can join. They must not be pregnant, agree to use contraception, and have a stable viral load. Excluded are those with severe allergies, heart disease, recent acute infections, advanced liver fibrosis or cancerous liver lesions.
What is being tested?
The trial is testing HepB mAb19, an experimental antibody targeting the hepatitis B virus in patients already on standard treatment. It's compared against a placebo (sterile saline). The study will look at safety and how well it works to control the virus.
What are the potential side effects?
Potential side effects may include allergic reactions due to the monoclonal antibody such as skin rashes or more serious conditions like anaphylaxis. Since this is a first-in-human study, close monitoring for any unexpected side effects is critical.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area under the curve (AUC) of HepB mAb19
Changes in ALT within 2,12, 24 and 48 weeks after administration
Changes in AST within 2,12, 24 and 48 weeks after administration.
+11 more
Secondary study objectives
Change in quantitative HBsAg levels from baseline (day 0) at each scheduled follow up visit.
Detection of HBsAg by a qualitative assay at each scheduled follow up visit.
Rate and severity of treatment-related adverse events during study follow up.
+1 more

Trial Design

9Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 5: Maximum tolerated dose, IVExperimental Treatment1 Intervention
Single intravenous infusion of HepB mAb19, dosed at the MTD
Group II: Group 4a: HepB mAb19 30 mg/kg, IVExperimental Treatment1 Intervention
Single intravenous infusion of HepB mAb19, dosed at 30 mg/kg.
Group III: Group 3a: HepB mAb19 10 mg/kg, IVExperimental Treatment1 Intervention
Single intravenous infusion of HepB mAb19, dosed at 10 mg/kg.
Group IV: Group 2a: HepB mAb19 3 mg/kg, IVExperimental Treatment1 Intervention
Single intravenous infusion of HepB mAb19, dosed at 3 mg/kg.
Group V: Group 1a: HepB mAb19 1 mg/kg, IVExperimental Treatment1 Intervention
Single intravenous infusion of HepB mAb19, dosed at 1 mg/kg.
Group VI: Group 2b: Placebo 3 mg/kg, IVPlacebo Group1 Intervention
Single intravenous infusion of placebo - normal saline, dosed at 3 mg/kg.
Group VII: Group 1b: Placebo 1 mg/kg, IVPlacebo Group1 Intervention
Single intravenous infusion of placebo - normal saline, dosed at 1 mg/kg.
Group VIII: Group 4b: Placebo 30 mg/kg, IVPlacebo Group1 Intervention
Single intravenous infusion of placebo - normal saline, dosed at 30 mg/kg.
Group IX: Group 3b: Placebo 10 mg/kg, IVPlacebo Group1 Intervention
Single intravenous infusion of placebo - normal saline, dosed at 10 mg/kg.

Find a Location

Who is running the clinical trial?

Rockefeller UniversityLead Sponsor
160 Previous Clinical Trials
16,489 Total Patients Enrolled
2 Trials studying Hepatitis B
22 Patients Enrolled for Hepatitis B
NYU Langone HealthOTHER
1,415 Previous Clinical Trials
856,166 Total Patients Enrolled
1 Trials studying Hepatitis B
200 Patients Enrolled for Hepatitis B
Marina Caskey, MDPrincipal InvestigatorThe Rockefeller University
15 Previous Clinical Trials
706 Total Patients Enrolled

Media Library

HepB mAb19 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05856890 — Phase 1
Hepatitis B Research Study Groups: Group 2b: Placebo 3 mg/kg, IV, Group 5: Maximum tolerated dose, IV, Group 4a: HepB mAb19 30 mg/kg, IV, Group 2a: HepB mAb19 3 mg/kg, IV, Group 1b: Placebo 1 mg/kg, IV, Group 1a: HepB mAb19 1 mg/kg, IV, Group 4b: Placebo 30 mg/kg, IV, Group 3a: HepB mAb19 10 mg/kg, IV, Group 3b: Placebo 10 mg/kg, IV
Hepatitis B Clinical Trial 2023: HepB mAb19 Highlights & Side Effects. Trial Name: NCT05856890 — Phase 1
HepB mAb19 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05856890 — Phase 1
~25 spots leftby Mar 2027
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