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Completed

NCT Number: NCT07595159

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

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

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Argo Investigative Site, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Solution for injection

BW-20507

Drug

Solution for injection

Primary outcomes

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

    Time frame: Up to 12 weeks

Secondary outcomes

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

    Time frame: Up to 12 weeks

    Measured in hours*nanograms per milliliter

  2. Cmax: The maximum concentration of BW-20507 in plasma

    Time frame: Up to 12 weeks

    Measured in nanograms per milliliter (ng/mL).

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

    Time frame: Up to 12 weeks

    Measured in hours.

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

    Time frame: Up to 12 weeks

    Measured in hours.

  5. HBsAg level change from baseline

    Time frame: Up tp 48 weeks

    Measured in IU/mL

Sponsors and collaborators

Lead sponsor

Shanghai Argo Biopharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Acronym: HBV

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 19, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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