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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

Primary Purpose

Chronic Hepatitis B

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

JNJ-440

Placebo

About this trial

This is an interventional other trial for Chronic Hepatitis B focused on measuring First in Human, Healthy Volunteers, Hepatitis B Virus, JNJ-64530440

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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 Criteria:

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

Sites / Locations

Seoul National University Hospital
Severance Hospital, Yonsei University Health System
Republican Clinical Hospital
Auckland Clinical Services
Research Unit of Hepatitis and Liver Cancer, Department.Biochemistry, Faculty of Medicine King Chulalongkorn Memorial Hospital
Srinagarind Hospital Department of Gastroenterology, Faculty of Medicine, Khon Kaen University
Limited Liability Company "ARENSIA EXPLORATORY MEDICINE"

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Part 1 (Healthy Participants): Single Ascending Dose (SAD)

Part 2 (Healthy Participants): Multiple Ascending Dose (MAD)

Part 3 (Chronic Hepatitis B [CHB] Participants): MAD

Arm Description

Participants in Cohorts 1 to 5 and 3 optional cohorts (Cohorts 6, 7 and 10) will receive a single dose of JNJ-440/placebo on Day 1. Two cohorts will receive a second dose of JNJ-440/placebo in a fed state (participants from Cohort 3 will also participate in Cohort 8) or as an alternative JNJ-440 formulation (participants from Cohort 2 will also participate in optional Cohort 9) after a washout window of at least 10 days. In Cohorts 1 to 4, study drug will be administered under fasted conditions; in the remaining cohorts, study drug will be administered under fasted/fed conditions depending on the results of the food effect evaluation.

Participants in Cohorts 1 and 2 will receive a once daily dose of JNJ-440/placebo for the duration of 7 days under fasted or fed conditions. Participants in an optional cohort (Cohort 3) may receive a once daily or twice daily dose of JNJ-440/placebo for the duration of 7 or 14 days under fasted or fed conditions. The starting dose for Cohort 1 in Part 2 will be determined by the Sponsor in consultation with the Principal Investigator based on the data from Part 1. Dose escalation will be performed only after review of safety and pharmacokinetic (PK) data after a minimum of 7 days of study drug administration.

Participants in Cohorts 1 and 2 and 3 optional cohorts (Cohorts 3, 4, and 5) will receive multiple ascending doses of JNJ-440/placebo once daily or twice daily for 28 days under fed or fasted conditions. The starting dose and formulation for Cohort 1 will be determined based on the review of available data in healthy participants from Part 1 (SAD) and Part 2 (MAD). Dose escalation will be performed only after review of safety, tolerability, and PK data after a minimum of 14 days of study drug administration from at least 8 CHB participants.

Outcomes

Primary Outcome Measures

Parts 1, 2, and 3: Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability

Number of participants with AE (any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship) will be reported.

Parts 1, 2, and 3: Number of Participants With Clinically Significant Changes in Physical Examination (Body Weight Measurement and Skin Examination)

A symptom directed physical examination (including body weight measurement and skin examination) will be performed to further assess number of participants with clinically significant changes.

Parts 1, 2, and 3: Number of Participants With Clinically Significant Changes in Vital Signs

Number of participants with clinically significant changes in the vital signs will be reported.

Parts 1, 2, and 3: Number of Participants With ECG Abnormalities

Number of participants with electrocardiogram (ECG) abnormalities will be reported.

Parts 1, 2, and 3: Number of Participants With Holter Monitoring Abnormalities

Number of participants with Holter monitoring abnormalities will be reported.

Parts 1, 2, and 3: Number of Participants With Clinical Laboratory Abnormalities

Number of participants with clinical laboratory abnormalities will be reported.

Part 1: Maximum Observed Plasma Concentration (Cmax)

The Cmax is the maximum observed plasma concentration.

Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])

The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.

Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])

The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.

Part 3: Maximum Observed Plasma Concentration (Cmax)

The Cmax is the maximum observed plasma concentration.

Part 3: Observed Plasma Concentration From Time 0 to tau Hours Postdose (C[0-tau])

C(0-tau) is defined as the observed plasma concentration from time 0 to tau hours postdose (tau = dosing interval).

Part 3: Area Under the Curve From Time Zero to End of Dosing Interval (AUC[0-tau])

The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption.

Secondary Outcome Measures

Part 1: Ratio of Cmax Values Between Test and Reference Ratio (Cmax, test/reference) for Different Dosage Forms

Ratio Cmax, test/reference is the ratio of individual Cmax values between test and reference treatment. Test = JNJ-440 in oral solution (Cohort 9) or tablet (Cohort 10), and reference = JNJ-440 in fasted conditions (Cohort 2 or Cohort 4-7 [depending on dose], respectively).

Part 1: Ratio of AUC(0-last) Values Between Test and Reference (Ratio AUC[0-last],test/reference) for Different Dosage Forms

Ratio AUC(0-last),test/ref is the ratio of individual AUC(0-last) values between test and reference treatment. Test = JNJ-440 in oral solution (Cohort 9) or tablet (Cohort 10), and reference = JNJ-440 in fasted conditions (Cohort 2 or Cohort 4-7 [depending on dose], respectively).

Part 1: Ratio of AUC(0-infinity) Values Between Test and Reference (Ratio AUC[0-infinity], test/reference) for Different Dosage Forms

Ratio AUC(0-infinity),test/ref is the ratio of individual AUC(0-infinity) values between test and reference treatment. Test = JNJ-440 in oral solution (Cohort 9) or tablet (Cohort 10), and ref = JNJ-440 in fasted conditions (Cohort 2 or Cohort 4-7 [depending on dose], respectively).

Part 1: Ratio of Cmax Values Between Fed and Fasted (Ratio Cmax, test/reference) Conditions

Ratio Cmax, test/reference is the ratio of individual Cmax values between test and reference treatment. Test = JNJ-440 in fed conditions (Cohort 8), and reference = JNJ-440 in fasted conditions (Cohort 3).

Part 1: Ratio of AUC(0-last) Values Between Fed and Fasted (Ratio AUC[0- last],test/reference)

Ratio AUC(0-last),test/ref is the ratio of individual AUC(0-last) values between test and reference treatment. Test = JNJ-440 in fed conditions (Cohort 8), and ref = JNJ-440 in fasted conditions (Cohort 3).

Part 1: Ratio of AUC(0-infinity) Values Between Fed and Fasted (Ratio AUC[0-infinity], test/reference)

Ratio AUC(0-infinity),test/ref is the ratio of individual AUC(0- infinity) values between test and reference treatment. Test = JNJ-440 in fed conditions (Cohort 8), and ref = JNJ-440 in fasted conditions (Cohort 3).

Part 3: Mean Change from Baseline in HBV DNA Levels

Changes of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels as assessed by mean change from baseline in HBV DNA will be evaluated.

Part 3: Percentage of Participants with HBV DNA Levels and Undetectable HBV DNA

Percentage of participants with HBV DNA levels such as less than (<) 100 international units per milliliter (IU/mL) and undetectable HBV DNA will be evaluated.

Part 3: Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels

The difference of HBsAg levels from baseline will be evaluated.

Part 3: Change From Baseline in Hepatitis B e Antigen (HBeAg) Levels

The difference of HBeAg levels from baseline will be evaluated.

Part 3: Relationship Between Plasma Concentration and Antiviral Activity

The potential association between antiviral activity (like HBV DNA or HBsAg or HBeAg) and plasma concentration of JNJ-440 will be assessed.

Part 3: Relationship Between Plasma Concentration and Select AEs or Laboratory Changes

The potential association between select AEs or laboratory changes and plasma concentration of JNJ-440 may be assessed. Based on the clinically relevant AEs or laboratory changes during the study, this analysis may be performed.

Part 3: Change From Baseline in HBV DNA (Antiviral Activity) in Chronic Hepatitis B (CHB) Participants with Sequence Variations in the HBV Genome

Sequence variations in the HBV genome will be assessed by sequencing of the viral genome. Antiviral activity will be assessed by measuring change from baseline in HBV DNA concentration and compared between participants with and without HBV sequence variations.

Part 3: Number of Participants with Emergence of Treatment Associated Mutations in the HBV Genome

Treatment induced emerging mutations will be assessed by comparing the HBV genome sequence obtained at baseline with sequences obtained post-baseline.

Parts 1, 2, and 3: Relationship Between JNJ-440 Plasma Concentrations and Time-Matched Change from Baseline QTcF

The relationship between plasma levels of JNJ-440 and Q-T interval corrected for heart rate according to Fridericia's formula (QTcF) exposure response relationship will be assessed.

Full Information

NCT ID

NCT03439488

First Posted

January 23, 2018

Last Updated

December 9, 2019

Sponsor

Alios Biopharma Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03439488

Brief Title

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

Official Title

A Multipart Phase 1, Double-Blind, Randomized, Placebo-Controlled, First-in-Human, Study of Orally Administered JNJ-440 to Evaluate the Safety, Tolerability, and Pharmacokinetics After Single Ascending Doses Including Food Effect Evaluation (Part 1); After Multi-Day Dosing (Part 2) in Healthy Subjects; and After Multiple (Ascending) Doses in Subjects With Chronic Hepatitis B (Part 3)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

March 26, 2018 (Actual)

Primary Completion Date

October 10, 2019 (Actual)

Study Completion Date

October 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alios Biopharma Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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 pharmacokinetic (PK) of JNJ-440 in healthy participants and in CHB participants following single and multiple dose regimens, administered alone (healthy participants and CHB participants).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis B

Keywords

First in Human, Healthy Volunteers, Hepatitis B Virus, JNJ-64530440

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

130 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1 (Healthy Participants): Single Ascending Dose (SAD)

Arm Type

Experimental

Arm Description

Arm Title

Part 2 (Healthy Participants): Multiple Ascending Dose (MAD)

Arm Type

Experimental

Arm Description

Arm Title

Part 3 (Chronic Hepatitis B [CHB] Participants): MAD

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

JNJ-440

Other Intervention Name(s)

JNJ-64530440 or ALS-003440

Intervention Description

JNJ-440 will be administered as oral tablets in Parts 1, 2 and 3. JNJ-440 may be provided as oral solution in a cohort in Part 1.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo as oral tablets will be administered in Parts 1, 2 and 3.

Primary Outcome Measure Information:

Title

Parts 1, 2, and 3: Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability

Description

Number of participants with AE (any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship) will be reported.

Time Frame

Approximately up to 8 weeks

Title

Parts 1, 2, and 3: Number of Participants With Clinically Significant Changes in Physical Examination (Body Weight Measurement and Skin Examination)

Description

A symptom directed physical examination (including body weight measurement and skin examination) will be performed to further assess number of participants with clinically significant changes.

Time Frame

Approximately up to 8 weeks

Title

Parts 1, 2, and 3: Number of Participants With Clinically Significant Changes in Vital Signs

Description

Number of participants with clinically significant changes in the vital signs will be reported.

Time Frame

Approximately up to 8 weeks

Title

Parts 1, 2, and 3: Number of Participants With ECG Abnormalities

Description

Number of participants with electrocardiogram (ECG) abnormalities will be reported.

Time Frame

Approximately up to 8 weeks

Title

Parts 1, 2, and 3: Number of Participants With Holter Monitoring Abnormalities

Description

Number of participants with Holter monitoring abnormalities will be reported.

Time Frame

Up to 24 hours post-dose on Day 1

Title

Parts 1, 2, and 3: Number of Participants With Clinical Laboratory Abnormalities

Description

Number of participants with clinical laboratory abnormalities will be reported.

Time Frame

Approximately up to 8 weeks

Title

Part 1: Maximum Observed Plasma Concentration (Cmax)

Description

The Cmax is the maximum observed plasma concentration.

Time Frame

Day 1 (predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, and 120 hours postdose)

Title

Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])

Description

The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.

Time Frame

Day 1 (predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, and 120 hours postdose)

Title

Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])

Description

Time Frame

Day 1 (predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, and 120 hours postdose)

Title

Part 3: Maximum Observed Plasma Concentration (Cmax)

Description

The Cmax is the maximum observed plasma concentration.

Time Frame

Day 1 (predose, and at 0.5, 1, 2, 4, 8, and 12 hours post dose), morning predose on Days 2, 15 and 21, and Day 28 (predose, and at 0.5, 1, 2, 4, 8, and 12 hours postdose; 24 hours postdose [once daily {QD} dosing only])

Title

Part 3: Observed Plasma Concentration From Time 0 to tau Hours Postdose (C[0-tau])

Description

C(0-tau) is defined as the observed plasma concentration from time 0 to tau hours postdose (tau = dosing interval).

Time Frame

Day 1 (predose, and at 0.5, 1, 2, 4, 8, and 12 hours post dose), morning predose on Days 2, 15 and 21, and Day 28 (predose, and at 0.5, 1, 2, 4, 8, and 12 hours postdose; 24 hours postdose [QD dosing only])

Title

Part 3: Area Under the Curve From Time Zero to End of Dosing Interval (AUC[0-tau])

Description

The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption.

Time Frame

Secondary Outcome Measure Information:

Title

Part 1: Ratio of Cmax Values Between Test and Reference Ratio (Cmax, test/reference) for Different Dosage Forms

Description

Time Frame

Day 1 (predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, and 120 hours postdose)

Title

Part 1: Ratio of AUC(0-last) Values Between Test and Reference (Ratio AUC[0-last],test/reference) for Different Dosage Forms

Description

Time Frame

Day 1 (predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, and 120 hours postdose)

Title

Part 1: Ratio of AUC(0-infinity) Values Between Test and Reference (Ratio AUC[0-infinity], test/reference) for Different Dosage Forms

Description

Time Frame

Day 1 (predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, and 120 hours postdose)

Title

Part 1: Ratio of Cmax Values Between Fed and Fasted (Ratio Cmax, test/reference) Conditions

Description

Time Frame

Day 1 (predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, and 120 hours postdose)

Title

Part 1: Ratio of AUC(0-last) Values Between Fed and Fasted (Ratio AUC[0- last],test/reference)

Description

Time Frame

Day 1 (predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, and 120 hours postdose)

Title

Part 1: Ratio of AUC(0-infinity) Values Between Fed and Fasted (Ratio AUC[0-infinity], test/reference)

Description

Time Frame

Day 1 (predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, 96, and 120 hours postdose)

Title

Part 3: Mean Change from Baseline in HBV DNA Levels

Description

Changes of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels as assessed by mean change from baseline in HBV DNA will be evaluated.

Time Frame

Baseline up to Day 56

Title

Part 3: Percentage of Participants with HBV DNA Levels and Undetectable HBV DNA

Description

Percentage of participants with HBV DNA levels such as less than (<) 100 international units per milliliter (IU/mL) and undetectable HBV DNA will be evaluated.

Time Frame

Baseline up to Day 56

Title

Part 3: Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels

Description

The difference of HBsAg levels from baseline will be evaluated.

Time Frame

Baseline up to Day 56

Title

Part 3: Change From Baseline in Hepatitis B e Antigen (HBeAg) Levels

Description

The difference of HBeAg levels from baseline will be evaluated.

Time Frame

Baseline up to Day 56

Title

Part 3: Relationship Between Plasma Concentration and Antiviral Activity

Description

The potential association between antiviral activity (like HBV DNA or HBsAg or HBeAg) and plasma concentration of JNJ-440 will be assessed.

Time Frame

Up to Day 56

Title

Part 3: Relationship Between Plasma Concentration and Select AEs or Laboratory Changes

Description

Time Frame

Up to Day 56

Title

Part 3: Change From Baseline in HBV DNA (Antiviral Activity) in Chronic Hepatitis B (CHB) Participants with Sequence Variations in the HBV Genome

Description

Time Frame

Baseline up to Day 56

Title

Part 3: Number of Participants with Emergence of Treatment Associated Mutations in the HBV Genome

Description

Treatment induced emerging mutations will be assessed by comparing the HBV genome sequence obtained at baseline with sequences obtained post-baseline.

Time Frame

Baseline up to Day 29

Title

Parts 1, 2, and 3: Relationship Between JNJ-440 Plasma Concentrations and Time-Matched Change from Baseline QTcF

Description

The relationship between plasma levels of JNJ-440 and Q-T interval corrected for heart rate according to Fridericia's formula (QTcF) exposure response relationship will be assessed.

Time Frame

Approximately up to 18 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeysen Yogaratnam

Organizational Affiliation

Alios Biopharma Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

Country

Korea, Republic of

Facility Name

Severance Hospital, Yonsei University Health System

City

Seoul

Country

Korea, Republic of

Facility Name

Republican Clinical Hospital

City

Chisnau

Country

Moldova, Republic of

Facility Name

Auckland Clinical Services

City

Auckland

ZIP/Postal Code

8963

Country

New Zealand

Facility Name

Research Unit of Hepatitis and Liver Cancer, Department.Biochemistry, Faculty of Medicine King Chulalongkorn Memorial Hospital

City

Bangkok

Country

Thailand

Facility Name

Srinagarind Hospital Department of Gastroenterology, Faculty of Medicine, Khon Kaen University

City

Khon Kaen

ZIP/Postal Code

40002

Country

Thailand

Facility Name

Limited Liability Company "ARENSIA EXPLORATORY MEDICINE"

City

Kapitanavka

ZIP/Postal Code

08112

Country

Ukraine

12. IPD Sharing Statement

Citations:

PubMed Identifier

35040959

Citation

Gane EJ, Schwabe C, Berliba E, Tangkijvanich P, Jucov A, Ghicavii N, Verbinnen T, Lenz O, Talloen W, Kakuda TN, Westland C, Patel M, Yogaratnam JZ, Dragone L, Van Remoortere P. Safety, antiviral activity and pharmacokinetics of JNJ-64530440, a novel capsid assembly modulator, as 4 week monotherapy in treatment-naive patients with chronic hepatitis B virus infection. J Antimicrob Chemother. 2022 Mar 31;77(4):1102-1110. doi: 10.1093/jac/dkab491.

Results Reference

derived

PubMed Identifier

35485346

Citation

Kakuda TN, Yogaratnam JZ, Westland C, Gane EJ, Schwabe C, Vuong J, Patel M, Snoeys J, Talloen W, Lenz O, Fry J, Chanda S, van Remoortere P. Pharmacokinetics, safety and tolerability of single- and multiple-ascending doses of JNJ-64530440, a novel hepatitis B virus capsid assembly modulator, in healthy volunteers. Antivir Ther. 2021 Jan-Feb;26(1-2):13-24. doi: 10.1177/13596535211044331. Epub 2021 Sep 23.

Results Reference

derived

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