Clinical trial NCT06744686: Phase 1 Study of HT-102 Administered Subcustaneously in Healthy Participants and Patients with Chronic Hepatitis B for Safety, Tolerability, Pharmacokinetics (PK), and Antiviral Activity (only in Participants with Chronic HBV Infection)
Official title: Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of HT-102Injection 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis B
Lead sponsor: Suzhou HepaThera Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-12-20
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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;

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: From administration to the end of treatment at 8 weeks
measure: Time to Reach Maximum Plasma Concentration (Tmax)
timeFrame: From administration to the end of treatment at 8 weeks
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: From administration to the end of treatment o at 10 weeks
measure: Area Under the Plasma Concentration Versus Time Curve (AUC)
timeFrame: From administration to the end of treatment o at 10 weeks
measure: Apparent Terminal Elimination Half-life (T1/2)
timeFrame: From administration to the end of treatment o at 10 weeks
measure: Apparent Plasma Clearance (CL/F)
timeFrame: From administration to the end of treatment o at 10 weeks
measure: Apparent volume of distribution（Vd/F）
timeFrame: From administration to the end of treatment o at 10 weeks
measure: Change of Serum HBsAg From Baseline
timeFrame: From administration to the end of treatment o at 10 weeks
measure: Change of Serum HBV DNA From Baseline
timeFrame: From administration to the end of treatment o at 10 weeks
measure: Change of Serum HBV RNA From Baseline
timeFrame: From administration to the end of treatment o at 10 weeks
measure: Change of Serum HBcrAg From Baseline
timeFrame: From administration to the end of treatment o at 10 weeks
measure: Change of Serum HBcAb From Baseline
timeFrame: From administration to the end of treatment o at 10 weeks
measure: Titers of Anti-drug Antibody (ADA) to HT-102
timeFrame: From administration to the end of treatment o at 10 weeks
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Mengchao Hepatobiliary Hospital of Fujian Medical University
state: Fujian
city: Qingyuan
country: China
facility: People's Hospital of Qingyuan
state: Guangdong
city: Luoyang
country: China
facility: Luoyang Central Hospital
state: Henan
city: Zhengzhou
country: China
facility: The Sixth People's Hospital of Zhengzhou
state: Henan
city: Jinan
country: China
facility: Shandong Public Health Clinical Center
state: Shandong
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: