Chronic Hepatitis BPhase 1HBVNCT07595159
A Study of BW-20507 in Chinese Healthy Subjects and Subjects With Chronic Hepatitis B
A Phase 1 study testing BW-20507 in people with Chronic Hepatitis B, run by Shanghai Argo Biopharmaceutical Co., Ltd. at 4 sites in China.
Trial summary
Phase 1 Study of BW-20507 in Healthy Subjects and Patients With Chronic Hepatitis B. Ia involved a single ascending dose study where healthy participants were administered one dose of BW-20507 or placebo subcutaneously. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- BW-20507
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 4 sitesChina
- Study dates
- 24 Jun 2024to 29 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
China4 sites
Argo Investigative Site
Beijing, Beijing Municipality, 100050
Argo Investigative Site
Chongqing, Chongqing Municipality, 404000
Argo Investigative Site
Guanzhou, Guangdong, 510700
Argo Investigative Site
Xuzhou, Jiangsu, 221000
About this study
Official title: A Phase 1 Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BW-20507 in Chinese Healthy Subjects and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity in Chinese Subjects With Chronic HBV Infection
Phase 1 Study of BW-20507 in Healthy Subjects and Patients With Chronic Hepatitis B. Ia involved a single ascending dose study where healthy participants were administered one dose of BW-20507 or placebo subcutaneously. Ib involved a multiple ascending dose study where participants with chronic hepatitis B virus infection were administered with multiple doses of BW-20507 SC
- Conditions
- Chronic Hepatitis B
- Being tested
- Placebo, BW-20507
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Solution for injection
BW-20507Drug
Solution for injection
| Study group | Role | What they receive |
|---|---|---|
| Ia | Experimental | Not described Receives: Drug: Placebo; Drug: BW-20507 |
| Ib | Experimental | Not described Receives: Drug: Placebo; Drug: BW-20507 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
Measured: Up to 12 weeks
Secondary outcomes (5)
AUC: The area under the BW-20507 plasma concentration-time curve
Measured in hours*nanograms per milliliter
Measured: Up to 12 weeks
Cmax: The maximum concentration of BW-20507 in plasma
Measured in nanograms per milliliter (ng/mL).
Measured: Up to 12 weeks
Tmax: The time from dosing to maximum plasma concentration of BW -20507
Measured in hours.
Measured: Up to 12 weeks
T1/2: Terminal half-life for BW -20507 after dosing
Measured in hours.
Measured: Up to 12 weeks
HBsAg level change from baseline
Measured in IU/mL
Measured: Up tp 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start24 Jun 2024
- Primary completion18 Nov 2025
- Study completion29 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Argo Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595159
- Sponsor's protocol ID
- BW-20507-1002
- Acronym
- HBV
- Status last verified
- May 2026
- First submitted
- 29 Mar 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BW-20507 in Chinese Healthy Subjects and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity in Chinese Subjects With Chronic HBV Infection
- ClinicalTrials.gov ID
- NCT07595159
- Acronym / sponsor ID
- HBV / BW-20507-1002
- Conditions
- Chronic Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Shanghai Argo Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- 29 Dec 2025 (actual)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 1 Study of BW-20507 in Healthy Subjects and Patients With Chronic Hepatitis B. Ia involved a single ascending dose study where healthy participants were administered one dose of BW-20507 or placebo subcutaneously. Ib involved a multiple ascending dose study where participants with chronic hepatitis B virus infection were administered with multiple doses of BW-20507 SC
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ia | Experimental | Drug: Placebo, Drug: BW-20507 |
| Ib | Experimental | Drug: Placebo, Drug: BW-20507 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboSolution for injection | Drug | Ia, Ib |
| BW-20507Solution for injection | Drug | Ia, Ib |
Primary outcome
Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to 12 weeks
5 secondary outcomes
AUC: The area under the BW-20507 plasma concentration-time curve
Time frame: Up to 12 weeks
Cmax: The maximum concentration of BW-20507 in plasma
Time frame: Up to 12 weeks
Tmax: The time from dosing to maximum plasma concentration of BW -20507
Time frame: Up to 12 weeks
T1/2: Terminal half-life for BW -20507 after dosing
Time frame: Up to 12 weeks
HBsAg level change from baseline
Time frame: Up tp 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BW-20507 in people with Chronic Hepatitis B, run by Shanghai Argo Biopharmaceutical Co., Ltd. at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse events (AEs) and serious adverse events (SAEs) (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.