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

NCT04030533 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR108639CNTO1959CRD1001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (10)

• 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 \[0-infinity\]).

  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

Secondary Outcomes (2)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  Up to Week 16

• Number of Participants with Anti-Guselkumab and Anti-Ustekinumab Antibodies

  Predose (Day 1) and on Days 15, 29, 57, and 85

Study Arms (5)

Cohort 1: Guselkumab (SC): Dose 1

EXPERIMENTAL

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

Drug: Guselkumab (SC): Dose 1

Cohort 2: Guselkumab (SC): Dose 2

EXPERIMENTAL

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

Drug: Guselkumab (SC): Dose 2

Cohort 3: Guselkumab (IV): Dose 1

EXPERIMENTAL

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

Drug: Guselkumab (IV): Dose 1

Cohort 4: Guselkumab (IV): Dose 2

EXPERIMENTAL

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

Drug: Guselkumab (IV): Dose 2

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.

Drug: Ustekinumab 6 mg/mL

Interventions

Guselkumab (SC): Dose 1 DRUG

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

Also known as: CNTO 1959

Cohort 1: Guselkumab (SC): Dose 1

Guselkumab (SC): Dose 2 DRUG

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

Also known as: CNTO 1959

Cohort 2: Guselkumab (SC): Dose 2

Guselkumab (IV): Dose 1 DRUG

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

Also known as: CNTO 1959

Cohort 3: Guselkumab (IV): Dose 1

Guselkumab (IV): Dose 2 DRUG

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

Also known as: CNTO 1959

Cohort 4: Guselkumab (IV): Dose 2

Ustekinumab 6 mg/mL DRUG

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

Also known as: Stelara

Cohort 5: Ustekinumab (IV): 6 mg/mL

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Peking University Third Hospital

Beijing, 100089, China

Location

MeSH Terms

Interventions

guselkumab; Ustekinumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 24, 2019
• Study Start: November 29, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)