A Study of BW-20507 in Chinese Healthy Subjects and Subjects With Chronic Hepatitis B

NCT07595159 | Completed Phase 1

• 1 other identifier: BW-20507-1002
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Number of subjects with adverse events (AEs) and serious adverse events (SAEs)

  Up to 12 weeks

Secondary Outcomes (5)

• AUC: The area under the BW-20507 plasma concentration-time curve

  Up to 12 weeks

• Cmax: The maximum concentration of BW-20507 in plasma

  Up to 12 weeks

• Tmax: The time from dosing to maximum plasma concentration of BW -20507

  Up to 12 weeks

• T1/2: Terminal half-life for BW -20507 after dosing

  Up to 12 weeks

• HBsAg level change from baseline

  Up tp 48 weeks

Study Arms (2)

Ia

EXPERIMENTAL

Drug: Placebo; Drug: BW-20507

Ib

EXPERIMENTAL

Drug: Placebo; Drug: BW-20507

Interventions

Placebo DRUG

Solution for injection

Ia; Ib

BW-20507 DRUG

Solution for injection

Ia; Ib

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Argo Biopharmaceutical Co., Ltd.: lead

Study Sites (4)

Argo Investigative Site

Beijing, Beijing Municipality, 100050, China

Location

Argo Investigative Site

Chongqing, Chongqing Municipality, 404000, China

Location

Argo Investigative Site

Guanzhou, Guangdong, 510700, China

Location

Argo Investigative Site

Xuzhou, Jiangsu, 221000, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2026
• First Posted: May 19, 2026
• Study Start: June 24, 2024
• Primary Completion: November 18, 2025
• Study Completion: December 29, 2025
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)