The purpose of the study is to characterize the pharmacokinetic (PK) profile of cetrelimab administered subcutaneous (SC) and optionally intravenous (IV) in chronic hepatitis B (CHB) participants.
Hepatitis B virus (HBV) is a small deoxyribonucleic acid (DNA) virus that infects the liver and can cause either acute (less than 6 months) or chronic (more than 6 months) infection. Persistence of HBV infection requires antigen-specific immune tolerance that prevents clearance of infected cells. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin (Ig) G4 kappa monoclonal antibody (mAb) that binds to programmed cell death receptor-1 (PD-1) with high affinity and specificity. PD-(L)1 inhibitors could possibly reverse the immune dysfunction from HBV. The study will be conducted in 3 phases: a screening phase (6 weeks), a single dose intervention phase (1 day), and a 24-week follow-up phase. The duration of individual participation will be up to 30 weeks. Key safety assessments include monitoring of Adverse Events (AEs), physical examination, vital signs, Electrocardiogram (ECGs), Injection site reaction (ISRs), Infusion-related reaction (IRRs), and clinical laboratory tests.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
11
Cetrelimab (Dose 1 and Dose 2) will be administered via SC injection or as an IV infusion.
Placebo will be administered via SC injection or as an IV infusion.
SGS Belgium NV
Edegem, Belgium
Az Sint-Maarten
Mechelen, Belgium
Hopital Beaujon
Clichy, France
Maximum Observed Serum Concentration (Cmax) of Cetrelimab
Cmax is defined as maximum observed serum concentration of cetrelimab.
Time frame: Up to 24 weeks
Area Under the Concentration-time Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) of Cetrelimab
AUC(0-last) is defined as area under the concentration-time curve from time 0 to the time of the last measurable concentration (non-below quantification limit \[non-BQL\]) of cetrelimab as calculated by linear-linear trapezoidal summation.
Time frame: Up to 24 weeks
Apparent Terminal Elimination Half-life (t1/2) of Cetrelimab
t1/2 is defined as apparent terminal elimination half-life of cetrelimab.
Time frame: Up to 24 weeks
Total Systemic Clearance of Cetrelimab
Total systemic clearance is a quantitative measure of the rate at which cetrelimab is removed from the body.
Time frame: Up to 24 weeks
Change from Baseline in HBsAg and HBeAg Levels Over Time
Change from baseline in Hepatitis B surface antigen (HBsAg), Hepatitis Be antigen (HBeAg) levels over time will be reported.
Time frame: Baseline up to 30 weeks
Change from Baseline in Hepatitis B Virus Deoxyribonucleic acid (HBV DNA) Levels Over Time
Change from baseline in HBV DNA levels over time will be reported.
Time frame: Baseline up to 30 weeks
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
APHP - Hopital Henri Mondor
Créteil, France
CHU Grenoble
Grenoble, France
Hopital Saint-Antoine
Paris, France
Universitaetsklinikum Essen
Essen, Germany
Medizinische Hochschule Hannover
Hanover, Germany
PUNKT ZDROWIA Hlebowicz Jakubowski Lekarze sp.p.
Gdansk, Poland
ID Clinic
Mysłowice, Poland
...and 3 more locations
Time frame: Up to 30 weeks
Cohorts 1,3 and 4: Number of Participants with Injection Site Reaction (ISR)
Number of Participants with ISR will be reported. An ISR is any adverse reaction at a subcutaneous (SC) study intervention injection-site.
Time frame: Up to 30 weeks
Number of Participants with Abnormalities in Clinical Laboratory Tests
Number of participants with abnormalities in clinical laboratory tests (including hematology, serum chemistry and urinalysis) will be reported.
Time frame: Up to 30 weeks