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

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• Status: Withdrawn
• Conditions: Healthy
• Intervention / Treatment: Drug: CR8020; Drug: Placebo

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: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Number of participants with adverse events	Up to 99 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed serum CR8020 concentration		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		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		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	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

• Sponsor: Janssen Pharmaceutical K.K.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Anticipated): April 1, 2014

Study Registration Dates

• First Submitted: December 13, 2013
• First Submitted That Met QC Criteria: December 13, 2013
• First Posted (Estimate): December 19, 2013

Study Record Updates

• Last Update Posted (Actual): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 21, 2019
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Safety; Healthy; Pharmacokinetics; Immunogenicity; Japanese; CR8020
• Other Study ID Numbers: CR102898; CR8020FLZ1002 (Other Identifier: Janssen Pharmaceutical K.K., Japan)