Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of HT-102 (BM012) Injection in Healthy Subjects and Hepatitis B e Antigen-Negative Patients with Chronic Hepatitis B Virus Infection: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Subcutaneous Injections, and Dose Escalation Phase 1 Clinical Study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
56
50mg, 150mg, 300mg, 600mg
50mg, 150mg, 300mg
Placebo
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
People's Hospital of Qingyuan
Qingyuan, Guangdong, China
Luoyang Central Hospital
Luoyang, Henan, China
The Sixth People's Hospital of Zhengzhou
Zhengzhou, Henan, China
Shandong Public Health Clinical Center
Jinan, Shandong, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From administration to the end of treatment at 8 weeks
Time to Reach Maximum Plasma Concentration (Tmax)
Time frame: From administration to the end of treatment at 8 weeks
Maximum Plasma Concentration (Cmax)
Time frame: From administration to the end of treatment o at 10 weeks
Area Under the Plasma Concentration Versus Time Curve (AUC)
Time frame: From administration to the end of treatment o at 10 weeks
Apparent Terminal Elimination Half-life (T1/2)
Time frame: From administration to the end of treatment o at 10 weeks
Apparent Plasma Clearance (CL/F)
Time frame: From administration to the end of treatment o at 10 weeks
Apparent volume of distribution(Vd/F)
Time frame: From administration to the end of treatment o at 10 weeks
Change of Serum HBsAg From Baseline
Time frame: From administration to the end of treatment o at 10 weeks
Change of Serum HBV DNA From Baseline
Time frame: From administration to the end of treatment o at 10 weeks
Change of Serum HBV RNA From Baseline
Time frame: From administration to the end of treatment o at 10 weeks
Change of Serum HBcrAg From Baseline
Time frame: From administration to the end of treatment o at 10 weeks
Change of Serum HBcAb From Baseline
Time frame: From administration to the end of treatment o at 10 weeks
Titers of Anti-drug Antibody (ADA) to HT-102
ADA analysis for predose and 8week (Part A) or 10weeks (Part B) postdose
Time frame: From administration to the end of treatment o at 10 weeks
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