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

Shanghai Argo Biopharmaceutical Co., Ltd.

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis B

Treatments: Drug: BW-20507; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07595159

BW-20507-1002

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

32 participants in 2 patient groups

Ia

Experimental group

Treatment:

Drug: Placebo

Drug: BW-20507

Ib

Experimental group

Treatment:

Drug: Placebo

Drug: BW-20507