Completed

NCT Number: NCT05017116

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

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.

Completed

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The University of Hong Kong

Hong Kong, China

About this study

The study consists of two parts. Part A is the single dose escalation study where subjects with chronic HBV infection will be assigned to receive single dose of RBD1016 or placebo . Part B is the multiple dose escalation study where subjects with chronic HBV infection will be assigned to receive two doses of RBD1016 or placebo.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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;
12-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.

Treatment and study plan

RBD1016

Drug

subcutaneous injection

Other names: RBD1016 injection

Placebo

Drug

subcutaneous injection

Entecavir

Drug

Take orally.

Primary outcomes

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

Time frame: up to 28 days

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

Time frame: up to 28 days

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.

Secondary outcomes

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

Time frame: up to 24 weeks

Electro chmiluminescence method will be used to detect hepatitis B surface antigen (HBsAg).
To draw the figure of HBsAb dynamic changes from baseline to Week 24 (Part A).

Time frame: up to 24 weeks

Electro chmiluminescence method will be used to detect hepatitis B surface antibody (HBsAb).
To draw the figure of HBeAg dynamic changes from baseline to Week 24 (Part A).

Time frame: up to 24 weeks

Electro chmiluminescence method will be used to detect hepatitis B e antigen (HBeAg).
To draw the figure of HBeAb dynamic changes from baseline to Week 24 (Part A).

Time frame: up to 24 weeks

Electro chmiluminescence method will be used to detect hepatitis B e antibody (HBeAb).
To draw the figure of HBcAb dynamic changes from baseline to Week 24 (Part A).

Time frame: up to 24 weeks

Electro chmiluminescence method will be used to detect hepatitis B core antibody (HBcAb).
To draw the figure of HBcrAg dynamic changes from baseline to Week 24 (Part A).

Time frame: up to 24 weeks

Electro chmiluminescence method will be used to detect hepatitis B core-related antigen (HBcrAg).
To draw the figure of HBV DNA dynamic changes from baseline to Week 24 (Part A).

Time frame: up to 24 weeks

PCR will be used to detect HBV DNA.
To draw the figure of HBV RNA dynamic changes from baseline to Week 24 (Part A).

Time frame: up to 24 weeks

PCR will be used to detect HBV RNA.
To draw the figure of peripheral blood T lymphocyte subsets dynamic changes from baseline to Week 24 (Part A).

Time frame: up to 24 weeks

Flow Cytometry will be used to detect peripheral blood T lymphocyte subsets.
To draw the figure of B cell dynamic changes from baseline to Week 24 (Part A).

Time frame: up to 24 weeks

Flow Cytometry will be used to detect B cell count.
To characterize the pharmacokinetic parameter Cmax (Part A).

Time frame: up to 85 days

PCR will be ued to detect Maximum concentration (Cmax) and PhoenixWinNonlin software (V8.0 or higher) will be used to calculate the PK parameters.
To characterize the pharmacokinetic parameter Tmax (Part A).

Time frame: up to 85 days

Time to maximum concentration (Tmax) will be calculated by PhoenixWinNonlin software (V8.0 or higher) will be used to calculate the PK parameter.
To characterize the pharmacokinetic parameter AUC0-t (Part A).

Time frame: up to 85 days

Area under the concentration-time curve from 0 to the collection time t (AUC0-t) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
To characterize the pharmacokinetic parameter AUC0-inf (Part A).

Time frame: up to 85 days

Area under the concentration-time curve from 0 to infinity (AUC0-inf) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
To characterize the pharmacokinetic parameter t1/2 (Part A).

Time frame: up to 85 days

Half-Life (t1/2) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
To characterize the pharmacokinetic parameter Vd (Part A).

Time frame: up to 85 days

Apparent volume of distribution (Vd) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
To characterize the pharmacokinetic parameter CL/F (Part A)

Time frame: up to 85 days

Clearance (CL/F) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
To draw the figure of HBsAg dynamic changes from baseline to Week 24 (Part B).

Time frame: up to 24 weeks

Electro chmiluminescence method will be used to detect hepatitis B surface antigen (HBsAg).
To draw the figure of HBsAb dynamic changes from baseline to Week 24 (Part B).

Time frame: up to 24 weeks

Electro chmiluminescence method will be used to detect hepatitis B surface antibody (HBsAb).
To draw the figure of HBeAg dynamic changes from baseline to Week 24 (Part B).

Time frame: up to 24 weeks

Electro chmiluminescence method will be used to detect hepatitis B e antigen (HBeAg).
To draw the figure of HBeAb dynamic changes from baseline to Week 24 (Part B).

Time frame: up to 24 weeks

Electro chmiluminescence method will be used to detect hepatitis B e antibody (HBeAb).
To draw the figure of HBcAb dynamic changes from baseline to Week 24 (Part B).

Time frame: up to 24 weeks

Electro chmiluminescence method will be used to detect hepatitis B core antibody (HBcAb).
To draw the figure of HBcrAg dynamic changes from baseline to Week 24 (Part B).

Time frame: up to 24 weeks

Electro chmiluminescence method will be used to detect hepatitis B core-related antigen (HBcrAg).
To draw the figure of HBV DNA dynamic changes from baseline to Week 24 (Part B).

Time frame: up to 24 weeks

PCR will be used to detect HBV DNA.
To draw the figure of HBV RNA dynamic changes from baseline to Week 24 (Part B).

Time frame: up to 24 weeks

PCR will be used to detect HBV RNA.
To draw the figure of peripheral blood T lymphocyte subsets dynamic changes from baseline to Week 24 (Part B).

Time frame: up to 24 weeks

Flow Cytometry will be used to detect peripheral blood T lymphocyte subsets.
To draw the figure of B cell dynamic changes from baseline to Week 24 (Part B).

Time frame: up to 24 weeks

Flow Cytometry will be used to detect B cell count.
To characterize the pharmacokinetic parameter Cmax (Part B).

Time frame: up to 113 days

PCR will be ued to detect Maximum concentration (Cmax) and PhoenixWinNonlin software (V8.0 or higher) will be used to calculate the PK parameters.
To characterize the pharmacokinetic parameter Tmax (Part B).

Time frame: up to 113 days

Time to maximum concentration (Tmax) will be calculated by PhoenixWinNonlin software (V8.0 or higher) will be used to calculate the PK parameter.
To characterize the pharmacokinetic parameter AUC0-t (Part B).

Time frame: up to 113 days

Area under the concentration-time curve from 0 to the collection time t (AUC0-t) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
To characterize the pharmacokinetic parameter AUC0-inf (Part B).

Time frame: up to 113 days

Area under the concentration-time curve from 0 to infinity (AUC0-inf) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
To characterize the pharmacokinetic parameter t1/2 (Part B).

Time frame: up to 113 days

Half-Life (t1/2) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
To characterize the pharmacokinetic parameter Vd (Part B).

Time frame: up to 113 days

Apparent volume of distribution (Vd) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
To characterize the pharmacokinetic parameter CL/F (Part B).

Time frame: up to 113 days

Clearance (CL/F) will be calculated by PhoenixWinNonlin software (V8.0 or higher).

Sponsors and collaborators

Lead sponsor

Suzhou Ribo Life Science Co. Ltd.

Industry

Registry information

Official study title

A Single and Repeated Dose Escalation, Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics and Preliminary Pharmacodynamics of RBD1016 in Subjects with Chronic Hepatitis B Virus (HBV) Infection

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Aug 23, 2021
Registry last updated: Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Key information

Conditions

Age range

Sex eligibility

Study type

Phase

Primary location

The University of Hong Kong

About this study

Who can participate

Treatment and study plan

RBD1016

Placebo

Entecavir

Primary outcomes

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

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

Secondary outcomes

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

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

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

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

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

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

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

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

To draw the figure of peripheral blood T lymphocyte subsets dynamic changes from baseline to Week 24 (Part A).

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

To characterize the pharmacokinetic parameter Cmax (Part A).

To characterize the pharmacokinetic parameter Tmax (Part A).

To characterize the pharmacokinetic parameter AUC0-t (Part A).

To characterize the pharmacokinetic parameter AUC0-inf (Part A).

To characterize the pharmacokinetic parameter t1/2 (Part A).

To characterize the pharmacokinetic parameter Vd (Part A).

To characterize the pharmacokinetic parameter CL/F (Part A)

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

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

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

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

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

To draw the figure of HBcrAg dynamic changes from baseline to Week 24 (Part B).

To draw the figure of HBV DNA dynamic changes from baseline to Week 24 (Part B).

To draw the figure of HBV RNA dynamic changes from baseline to Week 24 (Part B).

To draw the figure of peripheral blood T lymphocyte subsets dynamic changes from baseline to Week 24 (Part B).

To draw the figure of B cell dynamic changes from baseline to Week 24 (Part B).

To characterize the pharmacokinetic parameter Cmax (Part B).

To characterize the pharmacokinetic parameter Tmax (Part B).

To characterize the pharmacokinetic parameter AUC0-t (Part B).

To characterize the pharmacokinetic parameter AUC0-inf (Part B).

To characterize the pharmacokinetic parameter t1/2 (Part B).

To characterize the pharmacokinetic parameter Vd (Part B).

To characterize the pharmacokinetic parameter CL/F (Part B).

Sponsors and collaborators

Lead sponsor

Registry information

Official study title

Important dates

Related clinical trials

Analysis of Clinical Characteristics of Chronic Hepatitis B Combined With MAFLD in Different TCM Syndrome Types

Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2)

Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1)

A Study of BW-20507 in Chinese Healthy Subjects and Subjects With Chronic Hepatitis B