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)

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

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 Overview

• Status: Completed
• Conditions: Chronic Hepatitis B
• Intervention / Treatment: Drug: Placebo; Drug: HT-102; Drug: HT-102

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350025
      • Mengchao Hepatobiliary Hospital of Fujian Medical University
  • Guangdong
    • Qingyuan, Guangdong, China, 511518
      • People's Hospital of Qingyuan
  • Henan
    • Luoyang, Henan, China, 471000
      • Luoyang Central Hospital
    • Zhengzhou, Henan, China, 450015
      • The Sixth People's Hospital of Zhengzhou
  • Shandong
    • Jinan, Shandong, China, 250102
      • Shandong Public Health Clinical Center
  • Shanghai
    • Shanghai, Shanghai, China, 200080
      • Shanghai General Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 325035
      • The first Affiliated Hospital, Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A (Healthy participants administered with HT-102 or placebo); Healthy participants in all dose groups were randomly assigned to receive a single dose of HT-102 or placebo subcutaneously	Drug: Placebo; Placebo; Drug: HT-102; 50mg, 150mg, 300mg, 600mg; Drug: HT-102; 50mg, 150mg, 300mg
Experimental: Part B (Patients with CHB administered with HT-102 or placebo); Patients with chronic hepatitis B in all dose groups were randomly assigned to receive 5 dose of HT-102 or placebo subcutaneously every week.	Drug: Placebo; Placebo; Drug: HT-102; 50mg, 150mg, 300mg, 600mg; Drug: HT-102; 50mg, 150mg, 300mg

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Plasma Concentration (Cmax)		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
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
Change of Serum HBV DNA From Baseline		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	ADA analysis for predose and 8week (Part A) or 10weeks (Part B) postdose	From administration to the end of treatment o at 10 weeks

Collaborators and Investigators

• Sponsor: Suzhou HepaThera Biotech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2023
• Primary Completion (Actual): March 12, 2024
• Study Completion (Actual): June 18, 2024

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Pathologic Processes; Chronic Disease; Disease Attributes; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis A; Hepatitis; Hepatitis B; Hepatitis B, Chronic; Hepatitis, Chronic
• Other Study ID Numbers: HT-102-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No