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)

Suzhou HepaThera Biotech Co., Ltd.

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis B

Treatments: Drug: Placebo; Drug: HT-102

Study type: Interventional

Funder types: Industry

Identifiers

NCT06744686

HT-102-101

Details and patient eligibility

About

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

Enrollment: 56 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: HT-102

Drug: Placebo

Drug: HT-102

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

Experimental group

Description:

Patients with chronic hepatitis B in all dose groups were randomly assigned to receive 5 dose of HT-102 or placebo subcutaneously every week.

Treatment:

Drug: HT-102

Drug: Placebo

Drug: HT-102