Status:
COMPLETED
A Study of Orally Administered JNJ-440 to Evaluate the Safety, Tolerability, and Pharmacokinetics After Single Ascending Doses Including Food Effect Evaluation; After Multi-Day Dosing in Healthy Participants; and After Multiple (Ascending) Doses in Participants With Chronic Hepatitis B
Lead Sponsor:
Alios Biopharma Inc.
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of JNJ-440 in healthy and Chronic Hepatitis B (CHB) participants after single and multiple doses; and to evaluate the pharmacokinet...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Healthy Participants:
- Female participants (except for postmenopausal women) must have a negative pregnancy test at screening and on Day -1
- Participants must have a body mass index (BMI; weight in kilogram \[kg\] divided by the square of height in meters) of 18.0 to 30.0 kilogram per meter square (kg/m\^2), extremes included
- Participants must agree not to donate blood during the study and for at least 1 month after the completion of study drug administration
- Inclusion Criteria for Participants with Chronic Hepatitis B (CHB):
- Participant must have CHB infection documented by: (a) Serum hepatitis B surface antigen (HBsAg) positive at screening and at least 6 months prior to screening; (b) Serum antibody immunoglobulin M (IgM) anti-HBc antibody negative at screening
- Participants must currently not be receiving any CHB treatment at screening, that is, have never received treatment with hepatitis B virus (HBV) antiviral medicines, nucleos(t)ide analog (NAs), interferon (IFN) products, or investigational anti-HBV agents, OR Have not been on treatment with HBV antiviral medicines, NAs, or IFN products within 6 months prior to baseline (first intake of study drugs)
Exclusion
- Exclusion Criteria for Healthy Participants:
- Participants with a past history of cardiac arrhythmias (example, extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome) or history or other clinical evidence of significant or unstable cardiac disease (example, angina, congestive heart failure, myocardial infarction, diastolic dysfunction, significant arrhythmia, coronary heart disease, and/or clinically significant electrocardiogram \[ECG\] abnormalities), moderate to severe valvular disease or uncontrolled hypertension at screening. Any evidence of heart block or bundle branch block is also exclusionary
- Participants with any history of confirmed clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticarial
- Participants with a history of confirmed clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous studies with experimental drugs
- Exclusion Criteria for Participants with CHB:
- Participant with positivity of anti-HBs antibodies
- Participants with current hepatitis D virus (HDV) infection (confirmed by HDV antibody) at screening
Key Trial Info
Start Date :
March 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2019
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT03439488
Start Date
March 26 2018
End Date
October 10 2019
Last Update
February 3 2025
Active Locations (7)
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1
Republican Clinical Hospital
Chisnau, Moldova
2
Auckland Clinical Services
Auckland, New Zealand, 8963
3
Seoul National University Hospital
Seoul, South Korea
4
Severance Hospital, Yonsei University Health System
Seoul, South Korea