RecruitingPhase 1

HepB mAb19 in Individuals With Chronic Hepatitis B Infection

United States37 participantsStarted 2023-08-07

Plain-language 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).

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18 to 70; * HBV infection confirmed by positive HBsAg for \>/= 6 months; * On HBV-active nucleos(t)ide therapy for \>/= 6 months without change in NRTI in the previous 3 months; * The following laboratory values within 49 days from study entry (day 0): * HBV DNA below lower limit of quantification; * HBsAg \> 10 IU/mL; * HBs antibody negative; * Ability and willingness to provide informed consent; * For participants who can become pregnant (i.e., participants who have not been post-menopausal for at least 24 consecutive months, who have had menses within the preceding 24 months, or who have not undergone surgical sterilization, specifically hysterectomy and/or bilateral oophorectomy or bilateral salpingectomy), negative serum or urine pregnancy test at screening and on day 0 (study entry). * Participants who can become pregnant must agree to use two methods of contraception. * Partner sterilization with documentation of azoospermia prior to the participant's entry into the study, and this partner is the sole partner for that participant. The documentation of partner sterility can come from the site personnel's review of medical records or medical history interview provided by the participant or the partner. Self-reported documentation of reproductive potential should be entered in the source documents. * Participants who can impregnate a partner and who are engaging in sexual activity that could lead to pregnancy must agree to use condoms from 10 da…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate and severity of solicited adverse events that are Grade 2 or above within 2 weeks after administration.

Timeframe: 2 weeks

Rate and severity of treatment-emerging unsolicited adverse events that are Grade 2 or above (including confirmed laboratory abnormalities) within 2, 12, 24 and 48 weeks after administration.

Timeframe: 48 weeks

Rate and severity of participants with serious adverse events (SAEs) throughout the study period that are considered related to investigational product and the duration of those SAEs.

Timeframe: 48 weeks

Rate and severity of participants with potential immune complex disease (ICD) throughout the study period following investigational product (IP) administration.

Timeframe: 48 weeks

Changes in AST within 2,12, 24 and 48 weeks after administration.

Timeframe: 48 weeks

Changes in ALT within 2,12, 24 and 48 weeks after administration

Timeframe: 48 weeks

Trial details

NCT IDNCT05856890

SponsorRockefeller University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-01

Contact for this trial

Recruitment Specialist

800-782-2737 rucares@rockefeller.edu

View on ClinicalTrials.gov More Hepatitis b Virus trials

Plain-language summary

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Rate and severity of solicited adverse events that are Grade 2 or above within 2 weeks after administration.

Timeframe: 2 weeks

Rate and severity of treatment-emerging unsolicited adverse events that are Grade 2 or above (including confirmed laboratory abnormalities) within 2, 12, 24 and 48 weeks after administration.

Timeframe: 48 weeks

Rate and severity of participants with serious adverse events (SAEs) throughout the study period that are considered related to investigational product and the duration of those SAEs.

Timeframe: 48 weeks

Rate and severity of participants with potential immune complex disease (ICD) throughout the study period following investigational product (IP) administration.

Timeframe: 48 weeks

Changes in AST within 2,12, 24 and 48 weeks after administration.

Timeframe: 48 weeks

Changes in ALT within 2,12, 24 and 48 weeks after administration

Timeframe: 48 weeks