Overview

Study of Guselkumab and Ustekinumab Following a Single Intravenous or Subcutaneous Administration in Healthy Chinese Participants

Status:
Completed
Trial end date:
2020-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Janssen Research & Development, LLC
Treatments:
Antibodies, Monoclonal
Ustekinumab
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