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A Double-blind, Placebo-controlled, Randomized, Parallel, Single Dose Study to Investigate Pharmacokinetics, Safety, and Tolerability of JNJ-73763989 in Healthy Japanese Adult Participants

Hepatitis B complete ID: NCT04002752

The purpose of this study is to investigate the pharmacokinetics, safety, and tolerability of JNJ-73763989 in healthy Japanese adult participants following single-dose subcutaneous administration of 3 different doses of JNJ-73763989, Dose Level 1 (Panel A), Dose Level 2 (Panel B) or Dose Level 3 (Panel C).

Inclusion Criteria

  • Participant must be a Japanese participant who has resided outside Japan for no more than 10 years and whose parents and grandparents are Japanese, as determined by participant's verbal report
  • Participant 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 square meter (kg/m^2) extremes included, and body weight not less than 45.0 kg
  • Participant must be healthy on the basis of physical examination, clinical laboratory tests, medical history, and vital signs performed at screening. In case of abnormalities (except for those listed in the exclusion criteria) a participant may be included after all if the investigator judges the abnormalities not clinically significant or appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
  • A female participant of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test on Day -1
  • A male participant must agree not to donate sperm after enrollment (Day 1) in the study until at least 90 days after receiving the study drug

Timeline

  • July 4, 2019

    Start Date

  • August 23, 2019

    End Date

Trial Details

Start date:

July 4, 2019

End date:

August 23, 2019

Participants:

25

complete

Hepatitis B ID: NCT04002752

The purpose of this study is to investigate the pharmacokinetics, safety, and tolerability of JNJ-73763989 in healthy Japanese adult participants following single-dose subcutaneous administration of 3 different doses of JNJ-73763989, Dose Level 1 (Panel A), Dose Level 2 (Panel B) or Dose Level 3 (Panel C).

A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection (INSIGHT)

Hepatitis B active ID: NCT04585789

The title of protocol reflects the original study design. The study design section is reflecting that the design as of protocol amendment 5 is non-randomized.

Inclusion Criteria

  • Medically stable on the basis of physical examination, medical history, vital signs, and triplicate 12-lead electrocardiogram (ECG) performed at screening
  • Hepatitis B virus (HBV) infection with documentation at least 6 months prior to screening: participants be either currently not treated with HBeAg positive status or virologically (nucleos[t]ide analog [NA]) suppressed with HBeAg negative status
  • Hepatitis B surface antigen (HBsAg) greater than (>) 100 International Units per Milliliter (IU/mL) at screening
  • Body mass index (BMI) between 18.0 and 35.0 kilogram per meter square (kg/m^2), extremes included
  • Highly effective contraceptive measures in place for female participants of childbearing potential or male participants with female partners of childbearing potential
  • Fibroscan liver stiffness measurement less than and equal to (<=) 9 Kilopascal (kPa) within 6 months prior to screening or at the time of screening

Timeline

  • March 11, 2021

    Start Date

  • February 8, 2023

    End Date

Trial Details

Start date:

March 11, 2021

End date:

February 8, 2023

Participants:

24

Eligibility criteria:

18 Years to 65 Years (Adult, Older Adult)

active

Hepatitis B ID: NCT04585789

The purpose of this study is to assess changes in intrahepatic hepatitis B surface antigen (HBsAg) between baseline and on-treatment liver biopsy in response to JNJ-3989-based combination treatment.

A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus (REEF-D)

Hepatitis B active ID: NCT04535544

JNJ-73763989 is a liver-targeted antiviral therapeutic for subcutaneous injection designed to treat chronic hepatitis B virus (HBV) infection via ribonucleic acid interference mechanism. This phase 2 study is designed to evaluate safety and efficacy of JNJ-73763989 in HBV infected patients who are co-infected with HDV. The study consists of 2 parts: Part 1 will evaluate safety, tolerability and antiviral activity of JNJ-73763989 + NA while Part 2 will evaluate the safety and efficacy of the JNJ-73763989 + NA regimen in the treatment of HBV/HDV co-infection. Each part includes 3 phases: Screening phase (from 4 Week up to maximum of 8 weeks), Intervention phase (144 Week for Arm A and 148 Week for Arm B) and Follow-up phase (48 Week). The duration of individual study participation will be between 196 and 204 weeks. Safety and tolerability (including adverse events [AEs] and Serious AEs, laboratory assessments, electrocardiogram [ECG], vital signs, physical examination), efficacy (including HDV ribonucleic acid [RNA], HBV deoxyribonucleic acid [DNA] and antigens) , and pharmacokinetics will be assessed throughout the study.

Inclusion Criteria

  • Medically stable based on physical examination, medical history, vital signs, electrocardiogram (ECG) at screening
  • Chronic hepatitis B virus (HBV) and hepatitis D virus (HDV) co-infection with documentation at least 6 months prior to screening
  • For Part 1: hepatitis D RNA (HDV RNA) greater than or equal to (>=) 1000 international units per milliliter (IU/mL) at screening. For Part 2: must have HDV RNA values >= 500 IU/mL, and must have hepatitis B surface antigen (HBsAg) values less than or equal to (<=) 10000 IU/mL at screening or HDV RNA values at screening are <= 100000 IU/mL
  • Alanine aminotransferase (ALT) greater than upper limit normal (ULN) but less than 10 times (ULN)
  • Body mass index (BMI) between 18.0 and 35.0 kilogram per meter square (kg/m^2), extremes included
  • Highly effective contraceptive measures in place for female participants of childbearing potential or male participants with female partners of childbearing potential
  • Non-cirrhotic participants and participants with compensated cirrhosis (Child Pugh class A) at screening (Part 1) and participants must have absence of cirrhosis and platelet count of >= 140000 per deciliter (dL) for enrollment into Part-2

Timeline

  • September 17, 2020

    Study start date

  • October 16, 2023

    Study completion date

Trial Details

Start date:

September 17, 2020

End date:

October 16, 2023

Locations:

52

Eligibility criteria:

18 Years to 65 Years (Adult, Older Adult)

active

Hepatitis B ID: NCT04535544

The purpose of the study is to evaluate on-treatment efficacy against hepatitis D virus (HDV) of JNJ-73763989 + nucleos(t)ide analog (NA) regimen compared to NA alone.

A Study of JNJ-73763989 in Healthy Chinese Adult Participants

Hepatitis B complete ID: NCT04586439

The purpose of the study is to evaluate the single-dose Pharmacokinetics of JNJ-73763976 and JNJ-73763924 following a subcutaneous (SC) injection of JNJ-73763989 (JNJ-3989) in healthy Chinese adult participants at 2 different doses, Dose 1 (Panel A) or Dose 2 (Panel B).

Inclusion Criteria

  • Participant must be healthy based on physical examination, laboratory assessment, vital signs and electrocardiogram (ECG) at screening
  • A female participant of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [hCG]) pregnancy test at screening and a negative urine pregnancy test on Day -1
  • A male participant must agree not to donate sperm after enrollment (Day 1) in the study and a female participant must agree not to donate eggs (ova, oocytes) during the study until at least 90 days after receiving the study drug
  • Participant must not use nicotine-containing substances including tobacco products for at least 3 months prior to screening until completion of the study
  • Participant must have suitable veins for cannulation and/or repeated venipuncture

Timeline

  • N/A

    Study start date

  • February 18, 2021

    Study Completion date

Trial Details

Start date:

N/A

End date:

February 18, 2021

Participants:

18

Eligibility criteria:

18 Years to 55 Years (Adult)

complete

Hepatitis B ID: NCT04586439

The purpose of the study is to evaluate the single-dose Pharmacokinetics of JNJ-73763976 and JNJ-73763924 following a subcutaneous (SC) injection of JNJ-73763989 (JNJ-3989) in healthy Chinese adult participants at 2 different doses, Dose 1 (Panel A) or Dose 2 (Panel B).

A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection (REEF-1)

Hepatitis B complete ID: NCT03982186

Hepatitis B virus (HBV) is a small deoxyribonucleic acid virus that specifically infects the human liver. The acute phase of infection is either followed by an immune controlled state or progresses to chronic hepatitis B. The worldwide estimated prevalence of chronic HBV infection is about 292 million people affected. Hepatitis B surface antigen (HBsAg) seroclearance is currently considered to be associated with the most thorough suppression of HBV replication (termed functional cure). With current available NA treatment strategies, rate of HBsAg seroclearance remains very low (around 3 percent [%]) even under long-term treatment. Also, with the persistently high global prevalence of HBV-associated mortality, there is a medical need for more effective finite treatment options that lead to sustained HBsAg seroclearance. JNJ-73763989 is a liver-targeted antiviral therapeutic for subcutaneous injection designed to treat chronic HBV infection via ribonucleic acid interference mechanism. JNJ-56136379 is an orally administered capsid assembly modulator that is being developed for the treatment of chronic HBV infection. The aim of the study is to evaluate efficacy as measured by proportion of participants who completed 48-week study intervention and qualified for stopping NA treatment at Week 48. The study includes: Screening phase (4 weeks), Double-blind study intervention phase (from Day 1 up to Week 48), and Follow-up phase (48 weeks after end of investigational intervention with a maximum duration of 96 weeks). The duration of individual study participation will be between 100 and 150 weeks. Safety and tolerability (including adverse events [AEs] and Serious AEs, laboratory assessments, electrocardiogram [ECG], vital signs, physical examination), efficacy (including HBsAg seroclearance), and pharmacokinetics will be assessed throughout the study.

Inclusion Criteria

  • Medically stable based on physical examination, medical history, vital signs, electrocardiogram (ECG) at screening
  • Chronic hepatitis B virus (HBV) infection with documentation at least 6 months prior to screening
  • Hepatitis B surface antigen (HBsAg) greater than (>) 100 International Units per Milliliter (IU/mL) at screening
  • Body mass index (BMI) between 18.0 and 35.0 kilogram per meter square (kg/m^2), extremes included
  • Highly effective contraceptive measures in place for female participants of childbearing potential or male participants with female partners of childbearing potential
  • Liver fibrosis stage 0-2 (Metavir) or Fibroscan less than (<) 9 Kilopascal (kPa) at screening

Timeline

  • March 29, 2021

    Study start date

  • April 26, 2022

    Study completion date

Trial Details

Start date:

March 29, 2021

End date:

April 26, 2022

Participants:

471

Eligibility criteria:

18 Years to 65 Years (Adult, Older Adult)

complete

Hepatitis B ID: NCT03982186

The purpose of this study is to establish the dose-response relationship for antiviral activity of 3 dose levels of JNJ-73763989+nucleos(t)ide analog (NA) and to evaluate the efficacy of combination regimens of JNJ-73763989+NA (with and without JNJ-56136379) and of JNJ-56136379+NA.

A Phase 1 Clinical Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Effects of a Single Dose of VSA001 Injection in Chinese Healthy Adult Volunteers

Healthy planned ID: NCT05757596

This is a phase 1, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics effects of a single dose of VSA001 injection in Chinese healthy adult volunteers. Eligible enrolled participants will initially receive VSA001 injection at the assigned dose level.

Inclusion Criteria

  • The subjects voluntarily participate in this study who are able to read, understand, and sign the ICF before participation; and have a full understanding of the content, process and possible adverse reactions of the study and are able to complete the study in accordance with the requirements of the protocol.
  • Healthy male and female subjects aged between 18 and 55 years (both inclusive) at the time of informed consent.
  • Body mass index (BMI) = weight (kg)/height (m)2, within the range of 19.0-30.0 kg/m2 (both inclusive), and body weight no less than 50 kg.
  • In good general health and without clinically significant abnormalities as judged by the investigator, based on medical history, physical examination, vital signs, 12-lead ECG, and laboratory results.
  • Negative serum pregnancy test within 72 h prior to initiation of study treatment in all premenopausal females and females who have been amenorrheic for less than 12 months. (Serum pregnancy test is not required for females who have undergone surgical sterilization, such as hysterectomy and/or bilateral oophorectomy, or those who have not experienced menses for 12 consecutive months and are judged to be postmenopausal based on factors such as age and castration therapy).
  • Subjects and their partners must agree to use adequate contraceptive methods prior to initiation of study treatment, during the study, and for at least 3 months after discontinuation of study treatment.
  • Fasting serum TGs >80 mg/dL (>0.903 mmol/L) at screening.

Timeline

  • March 2023

    Study First Posted

  • June 2023

    Study Start Date

  • December 2023

    Estimated study completion date

Trial Details

Start date:

June 2023

End date:

December 2023

Locations:

China

Participants:

24

Eligibility criteria:

18 Years to 55 Years (Adult), All Sexes, Accepts Healthy Volunteers

planned

Healthy ID: NCT05757596

This is a phase 1, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics effects of a single dose of VSA001 injection in Chinese healthy adult volunteers. Eligible enrolled participants will initially receive VSA001 injection at the assigned dose level.

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ARC-520 in Normal Adult Volunteers

Healthy complete ID: NCT01872065

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of ARC-520 in normal, adult volunteers.

Inclusion Criteria

  • Healthy male or female subjects, 18-55 years of age
  • Be a non-smoker

Timeline

  • June 2013

    Study First Posted

  • July 2013

    Study Start Date

  • September 2014

    Actual study completion date

Trial Details

Start date:

July 2013

End date:

September 2014

Locations:

Australia

Participants:

54

Eligibility criteria:

18 Years to 55 Years (Adult), All Sexes, Accepts Healthy Volunteers

complete

Healthy ID: NCT01872065

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of ARC-520 in normal, adult volunteers.

A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ARC-520 at Varying Infusion Rates in Normal Adult Volunteers

Healthy complete ID: NCT02535416

This is a single-center, open-label, sequential cohort, single-dose study of ARC-520 administered intravenously to healthy adult volunteers. Eligible subjects will receive a single intravenous injection of ARC-520. Up to 8 cohorts (a total of approximately 40 subjects) may be enrolled. ARC-520 (4.0 mg/kg) will be administered at increasing infusion rates up to a bolus push in cohort 5. In addition dose levels at 5.0 mg/kg and 6.0 mg/kg will be evaluated at an infusion rate of 0.9 mL/min. For each subject the duration of the study clinic visits is approximately 6 weeks; maximum study duration is approximately 17 weeks including follow-up telephone calls at Days 30, 60 and 90.

Participants will undergo the following evaluations at regular intervals: medical history, physical examinations, bee venom allergy blood test, vital signs measurements, weight, adverse event monitoring, electrocardiograms (ECGs), telemetry, pregnancy test (females), concurrent medication, blood sample collection for hematology, coagulation, chemistry, pharmacokinetics, pharmacodynamics, and drug screens, and urinalysis.

Inclusion Criteria

  • Male or female, 18-55 years of age, inclusive
  • Able to provide written informed consent
  • BMI between 19.0 and 35.0 kg/m2, inclusive
  • 12-lead ECG at Screening and pre-dose with no clinically significant abnormalities
  • Highly effective, double barrier contraception (both male and female partners) during the study and for 3 months following the dose of ARC-520
  • Willing and able to comply with all study assessments
  • Suitable venous access for blood sampling
  • Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) and creatinine levels in the normal range
  • No abnormal finding of clinical relevance

Timeline

  • August 2015

    Study First Posted

  • September 2015

    Study Start Date

  • August 2016

    Estimated study completion date

Trial Details

Start date:

September 2015

End date:

August 2016

Locations:

Australia

Participants:

40

Eligibility criteria:

18 Years to 55 Years (Adult), All Sexes, Accepts Healthy Volunteers

complete

Healthy ID: NCT02535416

Single doses of ARC-520 will be evaluated at varying infusion rates and by slow bolus push.

A Phase 1 Single and Multiple Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Effect of ARO-AAT on Serum Alpha-1 Antitrypsin Levels in Normal Adult Volunteers

Alpha 1-Antitrypsin Deficiency complete ID: NCT03362242

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of ARO-AAT in healthy adult volunteers.

Inclusion Criteria

  • Women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception
  • Willing to provide written informed consent and to comply with study requirements
  • Non-smoker for at least one year
  • Normal lung function
  • No abnormal finding of clinical relevance at Screening
  • Normal AAT level at Screening visit

Timeline

  • December 2017

    Study First Posted

  • March 2018

    Study Start Date

  • October 2018

    Actual study completion date

Trial Details

Start date:

March 2018

End date:

October 2018

Locations:

New Zealand

Participants:

45

Eligibility criteria:

18 Years to 55 Years (Adult), All Sexes, Accepts Healthy Volunteers

complete

Alpha 1-Antitrypsin Deficiency ID: NCT03362242

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of ARO-AAT in healthy adult volunteers.

A Phase 1/2a Single Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetic Effects of ARO-HBV in Normal Adult Volunteers and Multiple Escalating Doses Evaluating Safety, Tolerability and Pharmacodynamic Effects in HBV Patients

Hepatitis B complete ID: NCT03365947

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of ARO-HBV in healthy adult volunteers and participants with hepatitis B virus (HBV).

Inclusion Criteria for Parts A & B

  • Women of childbearing potential must have a negative pregnancy test, cannot be breast feeding, and must be willing to use contraception.
  • Willing to provide written informed consent and comply with study requirements

Additional Inclusion Criteria for Part B

  • Diagnosis of chronic HBV infection
  • HbsAg at screening > or = 50 IU/mL
  • Liver Elastography score < or = 10.5

Timeline

  • December 2017

    Study First Posted

  • March 2018

    Study Start Date

  • April 2020

    Actual study completion date

Trial Details

Start date:

March 2018

End date:

April 2020

Locations:

Australia, Hong Kong, New Zealand

Participants:

114

Eligibility criteria:

18 Years to 65 Years (Adult, Older Adult), All Sexes, Accepts Healthy Volunteers

complete

Hepatitis B ID: NCT03365947

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of ARO-HBV in healthy adult volunteers and participants with hepatitis B virus (HBV).