Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A，single dose group | Experimental | Subjects will receive single dose RBD1016/placebo on D1 combined with antiviral drugs during the study period. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RBD1016 | Drug | subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To draw the figure of HBsAg dynamic changes from baseline to Week 24 (Part A). | Electro chmiluminescence method will be used to detect hepatitis B surface antigen (HBsAg). | up to 24 weeks |
| To draw the figure of HBsAb dynamic changes from baseline to Week 24 (Part A). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Walter Seto | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Hong Kong | Hong Kong | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C413685 | entecavir |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | subcutaneous injection |
|
| Entecavir | Drug | Take orally. |
|
Electro chmiluminescence method will be used to detect hepatitis B surface antibody (HBsAb). |
| up to 24 weeks |
| To draw the figure of HBeAg dynamic changes from baseline to Week 24 (Part A). | Electro chmiluminescence method will be used to detect hepatitis B e antigen (HBeAg). | up to 24 weeks |
| To draw the figure of HBeAb dynamic changes from baseline to Week 24 (Part A). | Electro chmiluminescence method will be used to detect hepatitis B e antibody (HBeAb). | up to 24 weeks |
| To draw the figure of HBcAb dynamic changes from baseline to Week 24 (Part A). | Electro chmiluminescence method will be used to detect hepatitis B core antibody (HBcAb). | up to 24 weeks |
| To draw the figure of HBcrAg dynamic changes from baseline to Week 24 (Part A). | Electro chmiluminescence method will be used to detect hepatitis B core-related antigen (HBcrAg). | up to 24 weeks |
| To draw the figure of HBV DNA dynamic changes from baseline to Week 24 (Part A). | PCR will be used to detect HBV DNA. | up to 24 weeks |
| To draw the figure of HBV RNA dynamic changes from baseline to Week 24 (Part A). | PCR will be used to detect HBV RNA. | up to 24 weeks |
| To draw the figure of peripheral blood T lymphocyte subsets dynamic changes from baseline to Week 24 (Part A). | Flow Cytometry will be used to detect peripheral blood T lymphocyte subsets. | up to 24 weeks |
| To draw the figure of B cell dynamic changes from baseline to Week 24 (Part A). | Flow Cytometry will be used to detect B cell count. | up to 24 weeks |
| To characterize the pharmacokinetic parameter Cmax (Part A). | PCR will be ued to detect Maximum concentration (Cmax) and PhoenixWinNonlin software (V8.0 or higher) will be used to calculate the PK parameters. | up to 85 days |
| To characterize the pharmacokinetic parameter Tmax (Part A). | Time to maximum concentration (Tmax) will be calculated by PhoenixWinNonlin software (V8.0 or higher) will be used to calculate the PK parameter. | up to 85 days |
| To characterize the pharmacokinetic parameter AUC0-t (Part A). | 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). | up to 85 days |
| To characterize the pharmacokinetic parameter AUC0-inf (Part A). | Area under the concentration-time curve from 0 to infinity (AUC0-inf) will be calculated by PhoenixWinNonlin software (V8.0 or higher). | up to 85 days |
| To characterize the pharmacokinetic parameter t1/2 (Part A). | Half-Life (t1/2) will be calculated by PhoenixWinNonlin software (V8.0 or higher). | up to 85 days |
| To characterize the pharmacokinetic parameter Vd (Part A). | Apparent volume of distribution (Vd) will be calculated by PhoenixWinNonlin software (V8.0 or higher). | up to 85 days |
| To characterize the pharmacokinetic parameter CL/F (Part A) | Clearance (CL/F) will be calculated by PhoenixWinNonlin software (V8.0 or higher). | up to 85 days |
| To draw the figure of HBsAg dynamic changes from baseline to Week 24 (Part B). | Electro chmiluminescence method will be used to detect hepatitis B surface antigen (HBsAg). | up to 24 weeks |
| To draw the figure of HBsAb dynamic changes from baseline to Week 24 (Part B). | Electro chmiluminescence method will be used to detect hepatitis B surface antibody (HBsAb). | up to 24 weeks |
| To draw the figure of HBeAg dynamic changes from baseline to Week 24 (Part B). | Electro chmiluminescence method will be used to detect hepatitis B e antigen (HBeAg). | up to 24 weeks |
| To draw the figure of HBeAb dynamic changes from baseline to Week 24 (Part B). | Electro chmiluminescence method will be used to detect hepatitis B e antibody (HBeAb). | up to 24 weeks |
| To draw the figure of HBcAb dynamic changes from baseline to Week 24 (Part B). | Electro chmiluminescence method will be used to detect hepatitis B core antibody (HBcAb). | up to 24 weeks |
| To draw the figure of HBcrAg dynamic changes from baseline to Week 24 (Part B). | Electro chmiluminescence method will be used to detect hepatitis B core-related antigen (HBcrAg). | up to 24 weeks |
| To draw the figure of HBV DNA dynamic changes from baseline to Week 24 (Part B). | PCR will be used to detect HBV DNA. | up to 24 weeks |
| To draw the figure of HBV RNA dynamic changes from baseline to Week 24 (Part B). | PCR will be used to detect HBV RNA. | up to 24 weeks |
| To draw the figure of peripheral blood T lymphocyte subsets dynamic changes from baseline to Week 24 (Part B). | Flow Cytometry will be used to detect peripheral blood T lymphocyte subsets. | up to 24 weeks |
| To draw the figure of B cell dynamic changes from baseline to Week 24 (Part B). | Flow Cytometry will be used to detect B cell count. | up to 24 weeks |
| To characterize the pharmacokinetic parameter Cmax (Part B). | PCR will be ued to detect Maximum concentration (Cmax) and PhoenixWinNonlin software (V8.0 or higher) will be used to calculate the PK parameters. | up to 113 days |
| To characterize the pharmacokinetic parameter Tmax (Part B). | Time to maximum concentration (Tmax) will be calculated by PhoenixWinNonlin software (V8.0 or higher) will be used to calculate the PK parameter. | up to 113 days |
| To characterize the pharmacokinetic parameter AUC0-t (Part B). | 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). | up to 113 days |
| To characterize the pharmacokinetic parameter AUC0-inf (Part B). | Area under the concentration-time curve from 0 to infinity (AUC0-inf) will be calculated by PhoenixWinNonlin software (V8.0 or higher). | up to 113 days |
| To characterize the pharmacokinetic parameter t1/2 (Part B). | Half-Life (t1/2) will be calculated by PhoenixWinNonlin software (V8.0 or higher). | up to 113 days |
| To characterize the pharmacokinetic parameter Vd (Part B). | Apparent volume of distribution (Vd) will be calculated by PhoenixWinNonlin software (V8.0 or higher). | up to 113 days |
| To characterize the pharmacokinetic parameter CL/F (Part B). | Clearance (CL/F) will be calculated by PhoenixWinNonlin software (V8.0 or higher). | up to 113 days |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |