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

NCT ID: NCT04030533

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-29
• Study Completion Date: 2020-12-31

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Cohort 1: Guselkumab (SC): Dose 1

Participants will receive a single subcutaneous (SC) injection of guselkumab (dose 1), administered on Day 1.

Group Type: EXPERIMENTAL

Guselkumab (SC): Dose 1

Intervention Type: DRUG

Participants will receive a single dose of guselkumab (dose 1) subcutaneously.

Cohort 2: Guselkumab (SC): Dose 2

Participants will receive a single SC injection of guselkumab (dose 2), administered on Day 1.

Group Type: EXPERIMENTAL

Guselkumab (SC): Dose 2

Intervention Type: DRUG

Participants will receive a single dose of guselkumab (dose 2) subcutaneously.

Cohort 3: Guselkumab (IV): Dose 1

Participants will receive a single intravenous (IV) infusion of guselkumab (dose 1), administered on Day 1.

Group Type: EXPERIMENTAL

Guselkumab (IV): Dose 1

Intervention Type: DRUG

Participants will receive a single IV infusion of guselkumab (dose 1).

Cohort 4: Guselkumab (IV): Dose 2

Participants will receive a single IV infusion of guselkumab (dose 2), administered on Day 1.

Group Type: EXPERIMENTAL

Guselkumab (IV): Dose 2

Intervention Type: DRUG

Participants will receive a single IV infusion of guselkumab (dose 2).

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.

Group Type: EXPERIMENTAL

Ustekinumab 6 mg/mL

Intervention Type: DRUG

Participants will receive a single IV infusion of ustekinumab 6 mg/mL solution.

Interventions

Guselkumab (SC): Dose 1

Participants will receive a single dose of guselkumab (dose 1) subcutaneously.

Intervention Type: DRUG

Guselkumab (SC): Dose 2

Participants will receive a single dose of guselkumab (dose 2) subcutaneously.

Intervention Type: DRUG

Guselkumab (IV): Dose 1

Participants will receive a single IV infusion of guselkumab (dose 1).

Intervention Type: DRUG

Guselkumab (IV): Dose 2

Participants will receive a single IV infusion of guselkumab (dose 2).

Intervention Type: DRUG

Ustekinumab 6 mg/mL

Participants will receive a single IV infusion of ustekinumab 6 mg/mL solution.

Intervention Type: DRUG

Other Intervention Names

CNTO 1959; CNTO 1959; CNTO 1959; CNTO 1959; Stelara

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Peking University Third Hospital

Beijing, , China

Countries

China

Other Identifiers

CNTO1959CRD1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108639

Identifier Type: -

Identifier Source: org_study_id