Clinical trial NCT04030533: Study of Guselkumab and Ustekinumab Following a Single Intravenous or Subcutaneous Administration in Healthy Chinese Participants
Official title: A Study to Evaluate the Pharmacokinetics of Guselkumab and Ustekinumab Following a Single Intravenous or Subcutaneous Administration in Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2019-07-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* Participants must be healthy with no clinically significant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments, urinalysis, measurement of vital signs, and electrocardiogram (ECG)
* A woman must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and Day-1
* Must agree to use an adequate contraception method as deemed appropriate by the investigator; to always use a condom during intercourse and to not donate sperm during the study and for 16 weeks after study drug administration
* Must be a nonsmoker or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study. However, during the inpatient portion of the study if smoking is not allowed in the inpatient unit, smokers will not be allowed to smoke cannot use nicotine replacement products
* Must agree to abstain from alcohol intake 48 hours before study drug administration and during the inpatient period of the study. After this time, participants must not consume more than 10 grams of alcohol (e.g. 250 milliliter (mL) beer with 5 percent (%) alcohol content) per day for the duration of the study

Exclusion Criteria:

* History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, gastro-intestinal disease, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
* Has had major surgery, (for example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
* Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
* Has received an experimental antibody or biologic therapy within the previous 6 months
* Has a history of, or ongoing, chronic, or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection

Primary outcomes:
measure: Maximum Observed Serum Concentration (Cmax)
timeFrame: 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
measure: Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
timeFrame: 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
measure: Area Under Serum Concentration From Time Zero to the Last Quantifiable Concentration (AUC [0-last])
timeFrame: 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
measure: Elimination Half-Life (T1/2)
timeFrame: 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
measure: Total Systemic Clearance (CL)
timeFrame: 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
measure: Volume of Distribution (Vz)
timeFrame: 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
measure: Time to Reach Maximum Observed Serum Concentration (Tmax)
timeFrame: 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
measure: Apparent Total Systemic Clearance (CL/F)
timeFrame: 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
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: 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
measure: Absolute Bioavailability (F [%])
timeFrame: 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
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to Week 16
measure: Number of Participants with Anti-Guselkumab and Anti-Ustekinumab Antibodies
timeFrame: Predose (Day 1) and on Days 15, 29, 57, and 85
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: