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)

NCT ID: NCT06744686

Last Updated: 2024-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-12
• Study Completion Date: 2024-06-18

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

Conditions

Chronic Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

HT-102

Intervention Type: DRUG

50mg, 150mg, 300mg, 600mg

Placebo

Intervention Type: DRUG

Placebo

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.

Group Type: EXPERIMENTAL

HT-102

Intervention Type: DRUG

50mg, 150mg, 300mg

Placebo

Intervention Type: DRUG

Placebo

Interventions

HT-102

50mg, 150mg, 300mg, 600mg

Intervention Type: DRUG

HT-102

50mg, 150mg, 300mg

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Suzhou HepaThera Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

China

Other Identifiers

HT-102-101

Identifier Type: -

Identifier Source: org_study_id