Peking University Third Hospital
Beijing, 100089, China
NCT Number: NCT04030533
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.
Looking for future studies?
Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Beijing, 100089, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive a single dose of guselkumab (dose 1) subcutaneously.
Other names: CNTO 1959
Participants will receive a single dose of guselkumab (dose 2) subcutaneously.
Other names: CNTO 1959
Participants will receive a single IV infusion of guselkumab (dose 1).
Other names: CNTO 1959
Participants will receive a single IV infusion of guselkumab (dose 2).
Other names: CNTO 1959
Participants will receive a single IV infusion of ustekinumab 6 mg/mL solution.
Other names: Stelara
Time frame: 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
The Cmax is the maximum observed serum concentration.
Time frame: 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
AUC (0-infinity) is the area under the serum concentration versus time curve from time zero to infinity with extrapolation of the terminal phase.
Time frame: 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
AUC (0-last) area under the serum concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration.
Time frame: 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 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).
Time frame: 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
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]).
Time frame: 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
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.
Time frame: 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
Tmax is time correspondent to the maximum observed serum concentration.
Time frame: 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 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.
Time frame: 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 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.
Time frame: 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 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.
Time frame: Up to Week 16
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.
Time frame: Predose (Day 1) and on Days 15, 29, 57, and 85
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.
Janssen Research & Development, LLC
Industry
A Study to Evaluate the Pharmacokinetics of Guselkumab and Ustekinumab Following a Single Intravenous or Subcutaneous Administration in Healthy Chinese Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06068257
Breast Cancer, Breast Diseases
Orlando, Florida, United States
View Trial DetailsNCT06702423
Healthy
London, United Kingdom
View Trial DetailsNCT07223164
Healthy
Irvine, California, United States
View Trial DetailsNCT05595902
Healthy
Kadıköy, Istanbul, Turkey (Türkiye)
View Trial Details