Chronic Hepatitis B
Conditions
Brief summary
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
Interventions
DRUGHT-102
50mg, 150mg, 300mg, 600mg
DRUGPlacebo
Placebo
Sponsors
Suzhou HepaThera Biotech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy Participants SAD: * Male participants weighed ≥ 50.0 kg, female participants weighed ≥ 45.0 kg; * Participants were healthy individuals; * Participants promise to have no plans to have a child, donate sperm or eggs and voluntarily take effective non-drug contraception measures during the trial and within 3 months after the end of the trial; Participants with Chronic HBV infection, MAD: * Chronic HBV infection, and HBeAg negative; * Patients who had received antiviral therapy for at least one year before screening and stabilization therapy with nucleoside (nucleotide) reverse transcriptase inhibitors for ≥ 3 months before screening (nucleoside (nucleotide) reverse transcriptase inhibitors;
Exclusion criteria
* Participants with a history of active pathological hemorrhage or those with bleeding tendency, or those with a history of neurological disease; * Participants with major trauma or major surgery within 3 months before trial screening; * Participants with a history of drug allergy; * Participants who used any drugs before trial screening or are using any drugs, including vitamins and Chinese herbal medicines; * Participants with abnormal results of ECG examination, laboratory test in the screening period which were judged as clinically significant; * Participants who cannot tolerate subcutaneous injection; * Patients with a previous clinical diagnosis of liver cirrhosis, or a history of alcoholic liver disease, autoimmune liver disease, inherited metabolic liver disease, and other liver diseases; * Participants with a clinically significant acute infection; * Women who were pregnant or lactating or had a positive pregnancy test result;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From administration to the end of treatment at 8 weeks |
| Time to Reach Maximum Plasma Concentration (Tmax) | From administration to the end of treatment at 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apparent Terminal Elimination Half-life (T1/2) | From administration to the end of treatment o at 10 weeks | — |
| Apparent Plasma Clearance (CL/F) | From administration to the end of treatment o at 10 weeks | — |
| Apparent volume of distribution（Vd/F） | From administration to the end of treatment o at 10 weeks | — |
| Change of Serum HBsAg From Baseline | From administration to the end of treatment o at 10 weeks | — |
| Maximum Plasma Concentration (Cmax) | From administration to the end of treatment o at 10 weeks | — |
| Change of Serum HBV RNA From Baseline | From administration to the end of treatment o at 10 weeks | — |
| Change of Serum HBcrAg From Baseline | From administration to the end of treatment o at 10 weeks | — |
| Change of Serum HBcAb From Baseline | From administration to the end of treatment o at 10 weeks | — |
| Titers of Anti-drug Antibody (ADA) to HT-102 | From administration to the end of treatment o at 10 weeks | ADA analysis for predose and 8week (Part A) or 10weeks (Part B) postdose |
| Change of Serum HBV DNA From Baseline | From administration to the end of treatment o at 10 weeks | — |
| Area Under the Plasma Concentration Versus Time Curve (AUC) | From administration to the end of treatment o at 10 weeks | — |
Countries
China
Outcome results
None listed