A Study to Assess the Safety, Pharmacokinetics and Immunogenicity of CR8020 in Japanese Healthy Participants

March 21, 2019 updated by: Janssen Pharmaceutical K.K.

A Randomized, Double-Blind, Placebo-Controlled Study in Healthy Japanese Subjects to Assess the Safety, Pharmacokinetics and Immunogenicity of CR8020 Following Single Intravenous Administration

The purpose of the study is to assess the safety, pharmacokinetics (what the body does to the drug) and immunogenicity (ability of a particular substance to provoke an immune response in the human body) of CR8020 in japanese healthy participants

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a randomized (study medication is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), placebo-controlled (placebo comparator is compared with the study medication to evaluate safety profile of the study medication in clinical study), single-dose study in Japanese healthy adult male participants. The study will include screening phase (28 to 2 days prior to the study medication administration), treatment phase (Study medication will be administered on Day 1), and follow-up phase (up to 99 days). Twelve participants will be randomly assigned to CR8020 50 mg/kg or placebo groups in a 2:1 ratio and receive an assigned treatment on Day 1. Safety will be assessed by evaluating adverse events, clinical laboratory tests, 12-lead Electrocardiogram, vital signs, and physical examination. Total maximum duration of participation of an individual participant will be 127 days.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Have signed an informed consent document
  • Body mass index between 18 and 30 kg/m2, with body weight greater than or equal to 50 kg at screening
  • Must agree to use an adequate contraception method (eg, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm from the study drug administration until Day 99
  • Blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic at screening
  • Non-smoker or participant who smokes no more than 10 cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before the study drug administration

Exclusion Criteria:

  • History of or current clinically significant medical illness determined by the investigators including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, and coagulation disorders
  • Clinically significant abnormal values for hematology, clinical chemistry or urinalysis
  • Clinically significant abnormal physical examination, vital signs or 12-lead electrocardiogram
  • A diagnosis of influenza infection or any constellation of clinical symptoms consistent with influenza infection within 14 days before the study drug administration is scheduled
  • Participants with a fever of over 37.5°C on Day -1 or at predose

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Placebo will be administered as a single 2-hour intravenous infusion.
Experimental: CR8020
Drug: CR8020
CR8020 50 mg/kg solution will be administered as a single 2-hour intravenous infusion.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: Up to 99 days
Up to 99 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum observed serum CR8020 concentration
Time Frame: Day 1 (predose, 0.5, 2.25, 4, and 8 hours), Day 2, Day 3, Day 4, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 99 or early withdrawal day
Day 1 (predose, 0.5, 2.25, 4, and 8 hours), Day 2, Day 3, Day 4, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 99 or early withdrawal day
Time to reach the maximum observed serum CR8020 concentration
Time Frame: Day 1 (predose, 0.5, 2.25, 4, and 8 hours), Day 2, Day 3, Day 4, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 99 or early withdrawal day
Day 1 (predose, 0.5, 2.25, 4, and 8 hours), Day 2, Day 3, Day 4, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 99 or early withdrawal day
Area under the serum CR8020 concentration-time curve
Time Frame: Day 1 (predose, 0.5, 2.25, 4, and 8 hours), Day 2, Day 3, Day 4, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 99 or early withdrawal day
Day 1 (predose, 0.5, 2.25, 4, and 8 hours), Day 2, Day 3, Day 4, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 99 or early withdrawal day
Level of antibodies to CR8020 in serum samples
Time Frame: Day 1 (predose), Day 29, Day 57, Day 99 or early withdrawal day
Level of antibodies to CR8020 in serum samples will evaluate immunogenicity.
Day 1 (predose), Day 29, Day 57, Day 99 or early withdrawal day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Pharmaceutical K.K.

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2014

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR102898
  • CR8020FLZ1002 (Other Identifier: Janssen Pharmaceutical K.K., Japan)

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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