| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 |
|---|---|
|
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.
|
| 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 | |||||||
|---|---|---|---|---|---|---|---|
| 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 | ||||||
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* 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 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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