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

Janssen (J&J Innovative Medicine)

Status and phase

Withdrawn

Phase 1

Conditions

Healthy

Treatments

Drug: CR8020

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02015533

CR8020FLZ1002 (Other Identifier)

CR102898

Details and patient eligibility

About

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

Full 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.

Sex

Male

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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