CompletedPhase 2

A Study of RBD1016 in CHB Participants

China, Sweden48 participantsStarted 2023-10-11

Plain-language summary

This study is a multi-center, randomized, double-blind, placebo-controlled clinical study to assess the safety, efficacy, PK and immunogenicity of RBD1016 injection on NAs background treatment in CHB participants.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Willing and able to give written informed consent for study participation;
✓. Male or female participants aged 18-65 years;
✓. Body mass index (BMI) within the range of 18-34 kilograms/square meter (kg/m2);
✓. Documented history of chronic hepatitis B virus (HBV) infection, by positive HBsAg and/or HBV DNA tests ≥ 6 months before screening;
✓. HBeAg positive or negative at screening;
✓. On a stable regimen (≥ 12 months before screening) of any approved first-line oral NAs;
✓. HBV DNA level \<100 IU/mL at screening;
✓. HBsAg level ≥50 IU/mL at screening;

Exclusion criteria

✕. Diagnosed with other liver diseases other than hepatitis B;
✕. History of liver cirrhosis or hepatic decompensation (e.g., ascites, varices bleeding, or hepatic encephalopathy) before or at screening;
✕. History of organ transplantation or previous or concurrent with hepatocellular carcinoma (HCC), or imaging findings suggesting a possibility of malignant liver lesions;
✕. Concurrent hepatitis C virus (HCV), human immunodeficiency virus (HIV), or diagnosis of syphilis, acute hepatitis A or acute hepatitis E;
✕. Laboratory results at screening as follows: serum alpha-fetoprotein (AFP) \>50 μg/L; serum albumin concentration \<3.0 g/dL; international normalized ratio (INR) \>1.5; platelet count \<90×10\^9/L; serum direct bilirubin (DB) \>2×ULN; serum creatinine concentration \>1.5×ULN or creatinine clearance \<60 mL/min (according to the Cockcroft-Gault equation); or any clinically significant laboratory outliers that the investigator believes may interfere with the interpretation of the efficacy and safety data in this study;
✕. Those who the investigator believes are not suitable to participate in the study due to other factors.

What they're measuring

safety: number and percentage of AEs

Timeframe: 24 weeks

efficacy: the maximum decline of HBsAg level

Timeframe: 24 weeks

Trial details

NCT IDNCT05961098

SponsorSuzhou Ribo Life Science Co. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-29

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