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New hepatitis b drug shows promise in first human tests

NCT ID NCT07595159

Disease control Sponsor: Shanghai Argo Biopharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This early-phase trial tested an experimental drug called BW-20507 in 32 people. First, healthy volunteers received a single dose to check safety. Then, people with chronic hepatitis B received multiple doses to see how the drug behaves in the body and whether it fights the virus. The main goal was safety, not effectiveness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BW-20507 (an experimental drug given as an injection)
What this could lead to
If successful, this could point toward a new treatment option for chronic hepatitis B, potentially helping control the virus long-term.
What could go wrong
This is a very early Phase 1 trial with only 32 participants, focused on safety. It is too small and early to know if the drug works or is safe for wider use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

32 people

The number who actually took part.

Started

Jun 2024

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Ia： * healthy male or female participants Ib： * Males or females aged 18 to 65 years (inclusive) at the time of informed consent * Body mass index (BMI) ≥18 and ≤28 kg/m2, with body weight \>50 kg (male) or 45 kg (female) * Serum hepatitis B surface antigen (HBsAg) positive for ≥6 months at screening Exclusion Criteria: Ia * unhealthy male or female participants * Any clinically significant chronic diseases of cardiovascular, respiratory, endocrine, immune, renal, gastrointestinal, skin, hematologic, neuropsychiatric, or other systems (excluding chronic HBV infection), or laboratory test abnormal (unrelated to chronic HBV infection) that, in the opinion of the Investigator, makes the subject unsuitable for participation in the study * Any other clinically significant chronic liver disorders in addition to chronic HBV infection, including but not limited to: alcoholic liver disease, moderate or above fatty liver, autoimmune liver disease, hereditary metabolic liver disease, etc. * Significant hepatic fibrosis or hepatic cirrhosis, i.e., FibroScan \>9.0 kPa within 1 month prior to screening, or liver paracentesis pathology showing advanced hepatic fibrosis (Metavir F3) or hepatic cirrhosis (Metavir F4) within 1 year prior to screening

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection hepatitis B virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic hepatitis B

Contacts and locations

Locations

  • Argo Investigative Site

    Beijing, Beijing Municipality, 100050, China

  • Argo Investigative Site

    Chongqing, Chongqing Municipality, 404000, China

  • Argo Investigative Site

    Guanzhou, Guangdong, 510700, China

  • Argo Investigative Site

    Xuzhou, Jiangsu, 221000, China

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