A Phase 1 interventional study of Cetrelimab and Placebo in Hepatitis B, Chronic, sponsored by Janssen Research & Development, LLC. Completed at 13 sites in 5 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-07-24.
Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Basic science
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 11 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.
Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Participants will receive cetrelimab Dose 1 or placebo via subcutaneous (SC) injection on Day 1.
Drug: Cetrelimab · Drug: Placebo
Participants will receive cetrelimab Dose 2 or placebo administered via an Intravenous (IV) infusion on Day 1 based on the data review of previous cohort(s) (safety and tolerability data through at least 6 weeks postdose as well as pharmacokinetic (PK) and receptor occupancy (RO) data through at least day 4 postdose).
Drug: Cetrelimab · Drug: Placebo
Participant will receive cetrelimab or placebo via SC injection based on the data review of previous cohort(s) (safety and tolerability data through at least 6 weeks postdose as well as PK and RO data through at least day 4 postdose).
Drug: Cetrelimab · Drug: Placebo
Participant will receive cetrelimab or placebo via SC injection based on the data review of previous cohorts (safety and tolerability data through at least 6 weeks postdose as well as PK and RO data through at least day 4 postdose).
Drug: Cetrelimab · Drug: Placebo
Cetrelimab (Dose 1 and Dose 2) will be administered via SC injection or as an IV infusion.
Also known as: JNJ-63723283
Placebo will be administered via SC injection or as an IV infusion.
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.
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
Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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