NCT03536325

Brief Summary

The purpose of this study is to assess the safety and tolerability of guselkumab following single-dose intravenous (IV) infusion in Japanese healthy male participants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started May 2018

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 24, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

May 31, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2018

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

5 months

First QC Date

May 15, 2018

Last Update Submit

January 21, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

    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.

    Up to approximately 20 weeks

Secondary Outcomes (7)

  • Maximum Observed Serum Concentration (Cmax)

    Day 1: predose, end of infusion (EOI) and 8 hours (h) post dose; Day 2: 24 h post dose; Day 3: 48 h post dose; Day 4: 72 h post dose; Day 5: 96 h; Day 6: 120 h; Day 7: 144 h post dose; Days 15, 22, 29, 43, 57, 71, 85, 99, and 113

  • Area Under the Serum Concentration Versus Time Curve from Time 0 to the Time Corresponding to the Last Quantifiable Plasma Concentration (AUC[0-last])

    Day 1: predose, EOI and 8 h post dose; Day 2: 24 h post dose; Day 3: 48 h post dose; Day 4: 72 h post dose; Day 5: 96 h; Day 6: 120 h; Day 7: 144 h post dose; Days 15, 22, 29, 43, 57, 71, 85, 99, and 113

  • Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])

    Day 1: predose, EOI and 8 h post dose; Day 2: 24 h post dose; Day 3: 48 h post dose; Day 4: 72 h post dose; Day 5: 96 h; Day 6: 120 h; Day 7: 144 h post dose; Days 15, 22, 29, 43, 57, 71, 85, 99, and 113

  • Terminal half-life (t1/2)

    Day 1: predose, EOI and 8 h post dose; Day 2: 24 h post dose; Day 3: 48 h post dose; Day 4: 72 h post dose; Day 5: 96 h; Day 6: 120 h; Day 7: 144 h post dose; Days 15, 22, 29, 43, 57, 71, 85, 99, and 113

  • Total Systemic Clearance (CL)

    Day 1: predose, EOI and 8 h post dose; Day 2: 24 h post dose; Day 3: 48 h post dose; Day 4: 72 h post dose; Day 5: 96 h; Day 6: 120 h; Day 7: 144 h post dose; Days 15, 22, 29, 43, 57, 71, 85, 99, and 113

  • +2 more secondary outcomes

Study Arms (3)

Cohort 1: Guselkumab Dose 1 or Placebo

EXPERIMENTAL

Participants will receive Dose 1 of guselkumab or matching placebo as an intravenous (IV) infusion on Day 1.

Drug: Guselkumab Dose 1Drug: Placebo

Cohort 2: Guselkumab Dose 2 or Placebo

EXPERIMENTAL

Participants will receive Dose 2 of guselkumab or matching placebo as an IV infusion on Day 1.

Drug: Guselkumab Dose 2Drug: Placebo

Cohort 3: Guselkumab Dose 3 or Placebo

EXPERIMENTAL

Participants will receive Dose 3 of guselkumab or matching placebo as an IV infusion on Day 1 based on safety data results received from Cohort 1 and 2.

Drug: Guselkumab Dose 3Drug: Placebo

Interventions

Guselkumab Dose 1DRUG

Participants will receive Dose 1 of guselkumab on Day 1.

Also known as: CNTO1959
Cohort 1: Guselkumab Dose 1 or Placebo
Guselkumab Dose 2DRUG

Participants will receive Dose 2 of guselkumab on Day 1.

Also known as: CNTO1959
Cohort 2: Guselkumab Dose 2 or Placebo
Guselkumab Dose 3DRUG

Participants will receive Dose 3 of guselkumab on Day 1.

Also known as: CNTO1959
Cohort 3: Guselkumab Dose 3 or Placebo
PlaceboDRUG

Participants will receive matching placebo on Day 1.

Cohort 1: Guselkumab Dose 1 or PlaceboCohort 2: Guselkumab Dose 2 or PlaceboCohort 3: Guselkumab Dose 3 or Placebo

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (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)
  • 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, if the inpatient site allows. However, if smoking is not allowed in the inpatient site, smokers will not be allowed to smoke while inpatient cannot use nicotine replacement products during the inpatient period, but may smoke at other times during the study, up to the maximum stated above
  • 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 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
  • Any medical contraindications preventing study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Souseikai Hakata Clinic

Fukuoka, 812-0025, Japan

Location

MeSH Terms

Interventions

guselkumab

Study Officials

  • Janssen Pharmaceutical K.K., Japan Clinical Trial

    Janssen Pharmaceutical K.K.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2018

First Posted

May 24, 2018

Study Start

May 31, 2018

Primary Completion

October 25, 2018

Study Completion

October 25, 2018

Last Updated

January 23, 2019

Record last verified: 2019-01

Locations

JP(1)