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)

NCT06744686 | Completed Phase 1

• 1 other identifier: HT-102-101
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 7

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• 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

Study Arms (2)

Part A (Healthy participants administered with HT-102 or placebo)

EXPERIMENTAL

Healthy participants in all dose groups were randomly assigned to receive a single dose of HT-102 or placebo subcutaneously

Drug: HT-102; Drug: Placebo

Part B (Patients with CHB administered with HT-102 or placebo)

EXPERIMENTAL

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: HT-102; Drug: Placebo

Interventions

HT-102 DRUG

50mg, 150mg, 300mg, 600mg

Part A (Healthy participants administered with HT-102 or placebo)

Placebo DRUG

Placebo

Part A (Healthy participants administered with HT-102 or placebo); Part B (Patients with CHB administered with HT-102 or placebo)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Suzhou HepaThera Biotech Co., Ltd.: lead

Study Sites (7)

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, 350025, China

Location

People's Hospital of Qingyuan

Qingyuan, Guangdong, 511518, China

Location

Luoyang Central Hospital

Luoyang, Henan, 471000, China

Location

The Sixth People's Hospital of Zhengzhou

Zhengzhou, Henan, 450015, China

Location

Shandong Public Health Clinical Center

Jinan, Shandong, 250102, China

Location

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 325035, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 20, 2024
• Study Start: June 12, 2023
• Primary Completion: March 12, 2024
• Study Completion: June 18, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)