- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03002025
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injection of JNJ-64304500 in Healthy Japanese and Caucasian Male Participants
September 27, 2017 updated by: Janssen Pharmaceutical K.K.
A Double-blind, Placebo-controlled, Randomized, Single-ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injection of JNJ-64304500 in Healthy Japanese and Caucasian Male Subjects
The primary purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) following single-dose subcutaneous (SC) injection of JNJ-64304500 in healthy Japanese male participants.
Study Overview
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tokyo, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Participant must have signed an informed consent document prior to any study related procedures indicating that they understand the purpose of the study including the procedures required and are willing to participate in the study
- Participant must be willing and able to adhere to the study visit schedule, prohibitions and restrictions specified in the protocol, and other protocol requirements
- Participant must have a body weight in the range of 60 to 90 kilogram (kg), inclusive, and a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m^2)
- Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. This determination must be recorded in the participant's source documents and initialed by the investigator
- Participant must be a non-smoker for at least 3 months prior to study enrollment
Exclusion Criteria:
- Participant has a 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, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Participant has an active acute or chronic infection (including chronic recurrent or invasive candidiasis) or diagnosed latent infection
- Participant has or has had a serious infection (example, sepsis, pneumonia or pyelonephritis), or have been hospitalized or received intravenous (IV) antibiotics for a serious infection during the 2 months prior to screening
- Participant has ever had a nontuberculous mycobacterial infection or opportunistic infection (eg, cytomegalovirus, pneumocystosis, and aspergillosis) prior to screening
- Participant has a history of active granulomatous infection, including histoplasmosis or coccidioidomycosis prior to screening
- If participant has had a chest radiograph within 3 months before study drug administration radiograph that shows an abnormality suggestive of a malignancy or current active infection, including tuberculosis (TB)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1: JNJ-64304500 50 milligram (mg) or placebo
Participants (Japanese) will receive single subcutaneous (SC) dose of JNJ-64304500 50 mg or placebo on Day 1.
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Participants will receive JNJ-64304500 as SC injection.
Participants will receive matching placebo to JNJ-64304500 as SC injection.
|
Experimental: Cohort 2: JNJ-64304500 150 mg or placebo
Participants (Japanese) will receive single SC dose of JNJ-64304500 150 mg or placebo on Day 1.
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Participants will receive JNJ-64304500 as SC injection.
Participants will receive matching placebo to JNJ-64304500 as SC injection.
|
Experimental: Cohort 3: JNJ-64304500 400 mg or placebo
Participants (Japanese) will receive single SC dose of JNJ-64304500 400 mg or placebo on Day 1.
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Participants will receive JNJ-64304500 as SC injection.
Participants will receive matching placebo to JNJ-64304500 as SC injection.
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Experimental: Cohort 4: JNJ-64304500 150 mg or placebo
Participants (Caucasian) will receive single subcutaneous (SC) dose of JNJ-64304500 150 mg or placebo on Day 1.
|
Participants will receive JNJ-64304500 as SC injection.
Participants will receive matching placebo to JNJ-64304500 as SC injection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
Time Frame: Up to End of Study (Day 112)
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Up to End of Study (Day 112)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Observed Serum Concentration (Cmax)
Time Frame: Up to End of Study (Day 112)
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The Cmax is the maximum observed serum analyte concentration.
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Up to End of Study (Day 112)
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Time to Reach Maximum Observed Serum Concentration (Tmax)
Time Frame: Up to End of Study (Day 112)
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The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
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Up to End of Study (Day 112)
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Elimination Half-Life (t1/2)
Time Frame: Up to End of Study (Day 112)
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Elimination half-life associated with the terminal slope Lambda (z) of the semi logarithmic drug concentration-time curve, calculated as 0.693/Lambda (z).
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Up to End of Study (Day 112)
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Apparent Volume of Distribution (Vd/F)
Time Frame: Up to End of Study (Day 112)
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The Vd/F is defined as Dose/[Lambda (z)*AUC (0-infinity)].
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Up to End of Study (Day 112)
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Apparent Total Clearance (CL/F)
Time Frame: Up to End of Study (Day 112)
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The CL/F is defined as Dose/AUC (0-infinity).
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Up to End of Study (Day 112)
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Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])
Time Frame: Up to End of Study (Day 112)
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The AUC (0-last) is the area under the serum concentration-time curve from time zero to last quantifiable time.
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Up to End of Study (Day 112)
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Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
Time Frame: Up to End of Study (Day 112)
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The AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(last)/lambda(z); wherein AUC(0-last) is area under the serum concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
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Up to End of Study (Day 112)
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Antibodies to JNJ-64304500
Time Frame: Up to End of Study (Day 112)
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Serum samples will be collected and screened for antibodies binding to JNJ-64304500 and the titer of confirmed positive samples will be reported.
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Up to End of Study (Day 112)
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Percentage of Natural Killer Group 2 Member D Receptor Occupancy (NKG2D RO) by JNJ-64304500
Time Frame: Up to End of Study (Day 112)
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Percentage of NKG2D receptors on natural killer (NK) cells and cluster of differentiation 8 (CD8)+ T cells that are occupied by JNJ-64304500 will be analyzed using a validated flow cytometry assay.
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Up to End of Study (Day 112)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2017
Primary Completion (Actual)
September 9, 2017
Study Completion (Actual)
September 9, 2017
Study Registration Dates
First Submitted
December 21, 2016
First Submitted That Met QC Criteria
December 21, 2016
First Posted (Estimate)
December 23, 2016
Study Record Updates
Last Update Posted (Actual)
September 29, 2017
Last Update Submitted That Met QC Criteria
September 27, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- CR108267
- 64304500CRD1001 (Other Identifier: Janssen Pharmaceutical K.K., Japan)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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