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

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

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis B
• Intervention / Treatment: Drug: Placebo; Drug: BW-20507

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100050
      • Argo Investigative Site
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 404000
      • Argo Investigative Site
  • Guangdong
    • Guanzhou, Guangdong, China, 510700
      • Argo Investigative Site
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221000
      • Argo Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ia	Drug: Placebo; Solution for injection; Drug: BW-20507; Solution for injection
Experimental: Ib	Drug: Placebo; Solution for injection; Drug: BW-20507; Solution for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of subjects with adverse events (AEs) and serious adverse events (SAEs)	Up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC: The area under the BW-20507 plasma concentration-time curve	Measured in hours*nanograms per milliliter	Up to 12 weeks
Cmax: The maximum concentration of BW-20507 in plasma	Measured in nanograms per milliliter (ng/mL).	Up to 12 weeks
Tmax: The time from dosing to maximum plasma concentration of BW -20507	Measured in hours.	Up to 12 weeks
T1/2: Terminal half-life for BW -20507 after dosing	Measured in hours.	Up to 12 weeks
HBsAg level change from baseline	Measured in IU/mL	Up tp 48 weeks

Collaborators and Investigators

• Sponsor: Shanghai Argo Biopharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2024
• Primary Completion (Actual): November 18, 2025
• Study Completion (Actual): December 29, 2025

Study Registration Dates

• First Submitted: March 29, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Pathologic Processes; Chronic Disease; Disease Attributes; Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis, Chronic; Hepatitis; Pathological Conditions, Signs and Symptoms; Hepatitis B; Hepatitis B, Chronic
• Other Study ID Numbers: BW-20507-1002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No