A Single and Repeated Dose Escalation of RBD1016 in Subjects with Chronic Hepatitis B Virus (HBV) Infection

NCT05017116 | Completed Phase 1

• 1 other identifier: RBHB1103-HK
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, placebo-controlled, single (Part A) and repeated dose (Part B) escalation, phase I clinical study to evaluate the safety, pharmacokinetics (PK) and preliminary pharmacodynamics (PD) of RBD1016 in subjects with chronic HBV infection.

Conditions

Chronic Hepatitis B

Keywords

CHB; chronic hepatitis B infection

Outcome Measures

Primary Outcomes (2)

• Adverse events (AEs) and serious adverse events (SAEs) within 28 days after treatment (Part A)

  All reported AE terms will be coded using Medical Dictionary for Drug Regulatory Affairs (MedDRA).AEs and SAEs occurred throughout the course of the study will be evaluated and graded based on NCI-CTCAE V5.0.

  up to 28 days

• Adverse events (AEs) and serious adverse events (SAEs) within 28 days after the last treatment(Part B)

  All reported AE terms will be coded using Medical Dictionary for Drug Regulatory Affairs (MedDRA).AEs and SAEs occurred throughout the course of the study will be evaluated and graded based on NCI-CTCAE V5.0.

  up to 28 days

Secondary Outcomes (34)

• To draw the figure of HBsAg dynamic changes from baseline to Week 24 (Part A).

  up to 24 weeks

• To draw the figure of HBsAb dynamic changes from baseline to Week 24 (Part A).

  up to 24 weeks

• To draw the figure of HBeAg dynamic changes from baseline to Week 24 (Part A).

  up to 24 weeks

• To draw the figure of HBeAb dynamic changes from baseline to Week 24 (Part A).

  up to 24 weeks

• To draw the figure of HBcAb dynamic changes from baseline to Week 24 (Part A).

  up to 24 weeks

Study Arms (2)

Part A，single dose group

EXPERIMENTAL

Subjects will receive single dose RBD1016/placebo on D1 combined with antiviral drugs during the study period.

Drug: RBD1016; Drug: Placebo; Drug: Entecavir

Part B, multiple dose group

EXPERIMENTAL

Subjects will receive two doses of RBD1016/placebo on D1 and D29 combined with antiviral drugs during the study period.

Drug: RBD1016; Drug: Placebo; Drug: Entecavir

Interventions

RBD1016 DRUG

subcutaneous injection

Also known as: RBD1016 injection

Part A，single dose group; Part B, multiple dose group

Placebo DRUG

subcutaneous injection

Part A，single dose group; Part B, multiple dose group

Entecavir DRUG

Take orally.

Part A，single dose group; Part B, multiple dose group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects who voluntarily participate in this clinical trial, are able to correctly understand and have signed the informed consent in writing;
• Male or female volunteer aged 18-55 years (inclusive);
• Body Mass Index (BMI) of 18-30 kg/m2 (inclusive);
• Subjects with chronic HBV infection, including immunotolerant subjects, treatment naïve subjects and treated subjects.
• Ability to cooperate with study staff and comply with the study requirements and follow the protocol-specified procedures.

You may not qualify if:

• Subjects with liver diseases other than hepatitis B, including hepatitis C, hemochromatosis, primary sclerosing cholangitis; alcoholic, drug-related or autoimmune liver diseases; primary liver cancer and indeterminate nodules on liver imaging test;
• A history or manifestations of liver decompensation (e.g. Child-Pugh Class B or C, or ascites, gastrointestinal bleeding, hepatic encephalopathy or spontaneous bacterial peritonitis, etc.);
• Transient elastography at screening revealing FibroScan value ≥ 9 kPa or liver biopsy evidencing hepatic fibrosis within 24 months;
• The following laboratory findings: total serum bilirubin\> 2×ULN; serum alpha-fetoprotein\>50μg/L; serum albumin \<3.5g/dL; international normalized ratio (INR)\> 1.25; serum creatinine \> 1.5×ULN; any laboratory outliers of clinical significance that in the investigator's opinion may interfere with the interpretation of efficacy or safety data;
• lead ECG abnormalities with clinical significance;
• Pregnant or lactating women or women of child-bearing potential who are unwilling to take effective contraception throughout the course of the study (refer to Appendix 3 for details);
• Other factors that in the investigator's opinion would make it inappropriate for the subject to participate in the study.

Sponsors & Collaborators

• Suzhou Ribo Life Science Co. Ltd.: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavir

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 Officials

• Walter Seto

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

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: August 10, 2021
• First Posted: August 23, 2021
• Study Start: August 9, 2021
• Primary Completion: October 25, 2023
• Study Completion: October 25, 2023
• Last Updated: December 6, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)