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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
Argo Investigative Site
Beijing, Beijing Municipality, China
Argo Investigative Site
Chongqing, Chongqing Municipality, China
Argo Investigative Site
Guanzhou, Guangdong, China
Argo Investigative Site
Xuzhou, Jiangsu, China
Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to 12 weeks
AUC: The area under the BW-20507 plasma concentration-time curve
Measured in hours\*nanograms per milliliter
Time frame: Up to 12 weeks
Cmax: The maximum concentration of BW-20507 in plasma
Measured in nanograms per milliliter (ng/mL).
Time frame: Up to 12 weeks
Tmax: The time from dosing to maximum plasma concentration of BW -20507
Measured in hours.
Time frame: Up to 12 weeks
T1/2: Terminal half-life for BW -20507 after dosing
Measured in hours.
Time frame: Up to 12 weeks
HBsAg level change from baseline
Measured in IU/mL
Time frame: Up tp 48 weeks
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