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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1959CRD1001 | Other Identifier | Janssen Research & Development, LLC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Guselkumab (SC): Dose 1 | Experimental | Participants will receive a single subcutaneous (SC) injection of guselkumab (dose 1), administered on Day 1. |
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| Cohort 2: Guselkumab (SC): Dose 2 | Experimental | Participants will receive a single SC injection of guselkumab (dose 2), administered on Day 1. |
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| Cohort 3: Guselkumab (IV): Dose 1 | Experimental | Participants will receive a single intravenous (IV) infusion of guselkumab (dose 1), administered on Day 1. |
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| Cohort 4: Guselkumab (IV): Dose 2 | Experimental | Participants will receive a single IV infusion of guselkumab (dose 2), administered on Day 1. |
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| Cohort 5: Ustekinumab (IV): 6 mg/mL | Experimental | Participants will receive a single IV infusion of ustekinumab 6 milligrams per milliliter (mg/mL) solution on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guselkumab (SC): Dose 1 | Drug | Participants will receive a single dose of guselkumab (dose 1) subcutaneously. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) | The Cmax is the maximum observed serum concentration. | Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85 |
| Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) | AUC (0-infinity) is the area under the serum concentration versus time curve from time zero to infinity with extrapolation of the terminal phase. | Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85 |
| Area Under Serum Concentration From Time Zero to the Last Quantifiable Concentration (AUC [0-last]) | AUC (0-last) area under the serum concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration. | Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85 |
| Elimination Half-Life (T1/2) | Elimination half-life is time measured for the serum concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). | Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85 |
| Total Systemic Clearance (CL) | CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose is estimated by dividing the total administered dose by the serum area under the serum concentration-time curve from time zero to infinite time (AUC [0-infinity]). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | Up to Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | 100089 | China |
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
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| Guselkumab (SC): Dose 2 | Drug | Participants will receive a single dose of guselkumab (dose 2) subcutaneously. |
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| Guselkumab (IV): Dose 1 | Drug | Participants will receive a single IV infusion of guselkumab (dose 1). |
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| Guselkumab (IV): Dose 2 | Drug | Participants will receive a single IV infusion of guselkumab (dose 2). |
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| Ustekinumab 6 mg/mL | Drug | Participants will receive a single IV infusion of ustekinumab 6 mg/mL solution. |
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| Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85 |
| Volume of Distribution (Vz) | The Vz is total volume of distribution at terminal phase after intravenous (IV) administration, defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. | Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85 |
| Time to Reach Maximum Observed Serum Concentration (Tmax) | Tmax is time correspondent to the maximum observed serum concentration. | Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85 |
| Apparent Total Systemic Clearance (CL/F) | Apparent total systemic clearance is clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85 |
| Apparent Volume of Distribution (Vz/F) | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after subcutaneous dose (Vz/F) is influenced by the fraction absorbed. | Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85 |
| Absolute Bioavailability (F [%]) | Absolute bioavailability is the percentage of the orally administered dose that is systemically available. It is calculated as (AUC [0-infinity] for test)/(AUC [0-infinity] for reference [ref])*(D for ref/D for test)*100, where the reference treatment is an intravenous administration, AUC (0-infinity) is area under the concentration-time curve from time zero to extrapolated infinite time, and D is the dose of administered drug. | Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85 |
| Number of Participants with Anti-Guselkumab and Anti-Ustekinumab Antibodies |
Participant's serum samples will be collected and screened for antibodies binding to guselkumab and ustekinumab using validated electrochemiluminescence immunoassay analyzer (ECLIA) method for evaluation of potential immunogenicity. |
| Predose (Day 1) and on Days 15, 29, 57, and 85 |
| ID | Term |
|---|---|
| C000588857 | guselkumab |
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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