| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Healthy | Drug: Guselkumab (SC): Dose 1 Drug: Guselkumab (SC): Dose 2 Drug: Guselkumab (IV): Dose 1 Drug: Guselkumab (IV): Dose 2 Drug: Ustekinumab 6 mg/mL | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 60 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | A Study to Evaluate the Pharmacokinetics of Guselkumab and Ustekinumab Following a Single Intravenous or Subcutaneous Administration in Healthy Chinese Subjects |
| Actual Study Start Date : | November 29, 2019 |
| Actual Primary Completion Date : | December 31, 2020 |
| Actual Study Completion Date : | December 31, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Cohort 1: Guselkumab (SC): Dose 1
Participants will receive a single subcutaneous (SC) injection of guselkumab (dose 1), administered on Day 1.
|
Drug: Guselkumab (SC): Dose 1
Participants will receive a single dose of guselkumab (dose 1) subcutaneously.
Other Name: CNTO 1959
|
|
Experimental: Cohort 2: Guselkumab (SC): Dose 2
Participants will receive a single SC injection of guselkumab (dose 2), administered on Day 1.
|
Drug: Guselkumab (SC): Dose 2
Participants will receive a single dose of guselkumab (dose 2) subcutaneously.
Other Name: CNTO 1959
|
|
Experimental: Cohort 3: Guselkumab (IV): Dose 1
Participants will receive a single intravenous (IV) infusion of guselkumab (dose 1), administered on Day 1.
|
Drug: Guselkumab (IV): Dose 1
Participants will receive a single IV infusion of guselkumab (dose 1).
Other Name: CNTO 1959
|
|
Experimental: Cohort 4: Guselkumab (IV): Dose 2
Participants will receive a single IV infusion of guselkumab (dose 2), administered on Day 1.
|
Drug: Guselkumab (IV): Dose 2
Participants will receive a single IV infusion of guselkumab (dose 2).
Other Name: CNTO 1959
|
|
Experimental: Cohort 5: Ustekinumab (IV): 6 mg/mL
Participants will receive a single IV infusion of ustekinumab 6 milligrams per milliliter (mg/mL) solution on Day 1.
|
Drug: Ustekinumab 6 mg/mL
Participants will receive a single IV infusion of ustekinumab 6 mg/mL solution.
Other Name: Stelara
|
| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
| China | |
| Peking University Third Hospital | |
| Beijing, China, 100089 | |
| Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 22, 2019 | ||||||
| First Posted Date ICMJE | July 24, 2019 | ||||||
| Last Update Posted Date | January 29, 2021 | ||||||
| Actual Study Start Date ICMJE | November 29, 2019 | ||||||
| Actual Primary Completion Date | December 31, 2020 (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 |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Study of Guselkumab and Ustekinumab Following a Single Intravenous or Subcutaneous Administration in Healthy Chinese Participants | ||||||
| Official Title ICMJE | A Study to Evaluate the Pharmacokinetics of Guselkumab and Ustekinumab Following a Single Intravenous or Subcutaneous Administration in Healthy Chinese Subjects | ||||||
| Brief Summary | The purpose of this study is to evaluate the pharmacokinetics (PK) of guselkumab following a single intravenous (IV) or subcutaneous (SC) administration in healthy Chinese participants; to evaluate the PK of ustekinumab following a single IV administration in healthy participants. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 1 | ||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) 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 |
60 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Actual Study Completion Date ICMJE | December 31, 2020 | ||||||
| Actual Primary Completion Date | December 31, 2020 (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 | 18 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 | China | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT04030533 | ||||||
| Other Study ID Numbers ICMJE | CR108639 CNTO1959CRD1001 ( Other Identifier: Janssen Research & Development, LLC ) |
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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 Research & Development, LLC | ||||||
| Study Sponsor ICMJE | Janssen Research & Development, LLC | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Janssen Research & Development, LLC | ||||||
| Verification Date | January 2021 | ||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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