Condition or disease | Intervention/treatment | Phase |
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Healthy | Drug: JNJ-73763989 Drug: Placebo | Phase 1 |
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 |
Arm | Intervention/treatment |
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Experimental: Panel A: JNJ-73763989 or Placebo
Participants will receive JNJ-73763989 (Dose Level 1) or matching placebo as single subcutaneous injection.
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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.
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Experimental: Panel B: JNJ-73763989 or Placebo
Participants will receive JNJ-73763989 (Dose Level 2) or matching placebo as single subcutaneous injection.
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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.
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Experimental: Panel C: JNJ-73763989 or Placebo
Participants will receive JNJ-73763989 (Dose Level 3) or matching placebo as single subcutaneous injection.
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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.
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Ages Eligible for Study: | 20 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
PAREXEL International | |
London, United Kingdom, HA1 3UJ |
Study Director: | Janssen Sciences Ireland UC Clinical Trial | Janssen Sciences Ireland UC |
Tracking Information | |||||||
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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 |
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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 |
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Condition ICMJE | Healthy | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
25 | ||||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Janssen Sciences Ireland UC | ||||||
Study Sponsor ICMJE | Janssen Sciences Ireland UC | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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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 |