Chronic Hepatitis B
Conditions
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
Interventions
DRUGPlacebo
Solution for injection
DRUGBW-20507
Solution for injection
Sponsors
Shanghai Argo Biopharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects with adverse events (AEs) and serious adverse events (SAEs) | Up to 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC: The area under the BW-20507 plasma concentration-time curve | Up to 12 weeks | Measured in hours\*nanograms per milliliter |
| Cmax: The maximum concentration of BW-20507 in plasma | Up to 12 weeks | Measured in nanograms per milliliter (ng/mL). |
| Tmax: The time from dosing to maximum plasma concentration of BW -20507 | Up to 12 weeks | Measured in hours. |
| T1/2: Terminal half-life for BW -20507 after dosing | Up to 12 weeks | Measured in hours. |
| HBsAg level change from baseline | Up tp 48 weeks | Measured in IU/mL |
Countries
China
Outcome results
None listed