免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / A Study of JNJ-73763989 in Healthy Japanese Adult Participants

A Study of JNJ-73763989 in Healthy Japanese Adult Participants

Study Description
Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Healthy Drug: JNJ-73763989 Drug: Placebo Phase 1

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: A Double-blind, Placebo-controlled, Randomized, Parallel, Single Dose Study to Investigate Pharmacokinetics, Safety, and Tolerability of JNJ-73763989 in Healthy Japanese Adult Participants
Actual Study Start Date : July 4, 2019
Actual Primary Completion Date : August 23, 2019
Actual Study Completion Date : August 23, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Panel A: JNJ-73763989 or Placebo
Participants will receive JNJ-73763989 (Dose Level 1) or matching placebo as single subcutaneous injection.
Drug: JNJ-73763989
Participants will receive JNJ-73763989 as single subcutaneous injection.

Drug: Placebo
Participants will receive placebo matching to JNJ-73763989 as single subcutaneous injection.

Experimental: Panel B: JNJ-73763989 or Placebo
Participants will receive JNJ-73763989 (Dose Level 2) or matching placebo as single subcutaneous injection.
Drug: JNJ-73763989
Participants will receive JNJ-73763989 as single subcutaneous injection.

Drug: Placebo
Participants will receive placebo matching to JNJ-73763989 as single subcutaneous injection.

Experimental: Panel C: JNJ-73763989 or Placebo
Participants will receive JNJ-73763989 (Dose Level 3) or matching placebo as single subcutaneous injection.
Drug: JNJ-73763989
Participants will receive JNJ-73763989 as single subcutaneous injection.

Drug: Placebo
Participants will receive placebo matching to JNJ-73763989 as single subcutaneous injection.

Outcome Measures
Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 [ Time Frame: Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose ]
    Cmax is the maximum observed plasma analyte concentration.

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 [ Time Frame: Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose ]
    Tmax is defined as actual sampling time to reach maximum observed plasma analyte concentration.

  3. Last Measurable Observed Plasma Concentration (Clast) of JNJ-73763989 [ Time Frame: Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose ]
    Clast is last measurable observed plasma analyte concentration.

  4. Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Measurable Concentration (AUC[0-last]) of JNJ-73763989 [ Time Frame: Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose ]
    AUC(0-last) is area under the plasma concentration-time curve from time zero to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation.

  5. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Up to 30 days after last study drug administration (Up to 7 weeks) ]
    AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Exclusion Criteria:

  • Participant with a history of cardiac arrhythmias (for example, premature ventricular contractions), history of risk factors for Torsade de Pointes syndrome (for example, hypokalemia, family history of long QT Syndrome)
  • Female participant who is pregnant, breast-feeding, or planning to become pregnant during the study or within 90 days after receiving the study drug (or longer, if dictated by local regulation)
  • Male participants who plan to father a child during the study or within 90 days after receiving the study drug (or longer, if dictated by local regulation)
  • Participant with human immunodeficiency virus type 1 (HIV-1) or type 2 (HIV-2) infection (confirmed by antibodies) at screening
  • Participant with current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin M [IgM]), or hepatitis B infection (confirmed by Hepatitis B surface antigen [HBsAg]), or hepatitis C virus (HCV) infection (confirmed by HCV antibody), or hepatitis E infection (confirmed by hepatitis E antibody IgM) at screening
Contacts and Locations

Locations
Layout table for location information
United Kingdom
PAREXEL International
London, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Janssen Sciences Ireland UC
Investigators
Layout table for investigator information
Study Director: Janssen Sciences Ireland UC Clinical Trial Janssen Sciences Ireland UC
Tracking Information
First Submitted Date  ICMJE June 27, 2019
First Posted Date  ICMJE July 1, 2019
Last Update Posted Date September 26, 2019
Actual Study Start Date  ICMJE July 4, 2019
Actual Primary Completion Date August 23, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
  • Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 [ Time Frame: Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose ]
    Cmax is the maximum observed plasma analyte concentration.
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 [ Time Frame: Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose ]
    Tmax is defined as actual sampling time to reach maximum observed plasma analyte concentration.
  • Last Measurable Observed Plasma Concentration (Clast) of JNJ-73763989 [ Time Frame: Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose ]
    Clast is last measurable observed plasma analyte concentration.
  • Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Measurable Concentration (AUC[0-last]) of JNJ-73763989 [ Time Frame: Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose ]
    AUC(0-last) is area under the plasma concentration-time curve from time zero to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation.
  • Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Up to 30 days after last study drug administration (Up to 7 weeks) ]
    AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of JNJ-73763989 in Healthy Japanese Adult Participants
Official Title  ICMJE A Double-blind, Placebo-controlled, Randomized, Parallel, Single Dose Study to Investigate Pharmacokinetics, Safety, and Tolerability of JNJ-73763989 in Healthy Japanese Adult Participants
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: JNJ-73763989
    Participants will receive JNJ-73763989 as single subcutaneous injection.
  • Drug: Placebo
    Participants will receive placebo matching to JNJ-73763989 as single subcutaneous injection.
Study Arms  ICMJE
  • Experimental: Panel A: JNJ-73763989 or Placebo
    Participants will receive JNJ-73763989 (Dose Level 1) or matching placebo as single subcutaneous injection.
    Interventions:
    • Drug: JNJ-73763989
    • Drug: Placebo
  • Experimental: Panel B: JNJ-73763989 or Placebo
    Participants will receive JNJ-73763989 (Dose Level 2) or matching placebo as single subcutaneous injection.
    Interventions:
    • Drug: JNJ-73763989
    • Drug: Placebo
  • Experimental: Panel C: JNJ-73763989 or Placebo
    Participants will receive JNJ-73763989 (Dose Level 3) or matching placebo as single subcutaneous injection.
    Interventions:
    • Drug: JNJ-73763989
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 25, 2019)
25
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2019)
24
Actual Study Completion Date  ICMJE August 23, 2019
Actual Primary Completion Date August 23, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Exclusion Criteria:

  • Participant with a history of cardiac arrhythmias (for example, premature ventricular contractions), history of risk factors for Torsade de Pointes syndrome (for example, hypokalemia, family history of long QT Syndrome)
  • Female participant who is pregnant, breast-feeding, or planning to become pregnant during the study or within 90 days after receiving the study drug (or longer, if dictated by local regulation)
  • Male participants who plan to father a child during the study or within 90 days after receiving the study drug (or longer, if dictated by local regulation)
  • Participant with human immunodeficiency virus type 1 (HIV-1) or type 2 (HIV-2) infection (confirmed by antibodies) at screening
  • Participant with current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin M [IgM]), or hepatitis B infection (confirmed by Hepatitis B surface antigen [HBsAg]), or hepatitis C virus (HCV) infection (confirmed by HCV antibody), or hepatitis E infection (confirmed by hepatitis E antibody IgM) at screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04002752
Other Study ID Numbers  ICMJE CR108646
2019-000629-31 ( EudraCT Number )
73763989HPB1001 ( Other Identifier: Janssen Sciences Ireland UC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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
URL: https://www.janssen.com/clinical-trials/transparency
Responsible Party Janssen Sciences Ireland UC
Study Sponsor  ICMJE Janssen Sciences Ireland UC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Sciences Ireland UC Clinical Trial Janssen Sciences Ireland UC
PRS Account Janssen Sciences Ireland UC
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP