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)

Phase 1

Completed

• Conditions: Chronic Hepatitis B
• Interventions: Drug: HT-102; Drug: Placebo

• Registration Number: NCT06744686
• Lead Sponsor: Suzhou HepaThera Biotech Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-12
• Primary Completion: 2024-03-12
• Study Completion: 2024-06-18
• Status Verified: 2024-12
• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-16
• Last Update Submitted: 2024-12-16
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part A (Healthy participants administered with HT-102 or placebo)	HT-102	Healthy participants in all dose groups were randomly assigned to receive a single dose of HT-102 or placebo subcutaneously
Part A (Healthy participants administered with HT-102 or placebo)	Placebo	Healthy participants in all dose groups were randomly assigned to receive a single dose of HT-102 or placebo subcutaneously
Part B (Patients with CHB administered with HT-102 or placebo)	HT-102	Patients with chronic hepatitis B in all dose groups were randomly assigned to receive 5 dose of HT-102 or placebo subcutaneously every week.
Part B (Patients with CHB administered with HT-102 or placebo)	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 HBV DNA From Baseline	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 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

Trial Locations

Locations (7)

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, China

The First Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China