Healthy
Conditions
Keywords
Healthy, CR6261, Japanese, Safety, Pharmacokinetics, Immunogenicity
Brief summary
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 CR6261 in Japanese healthy participants
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 76 days). Twelve participants will be randomly assigned to CR6261 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 104 days.
Interventions
DRUGCR6261
CR6261 50 mg/kg solution will be administered as a single 2-hour intravenous infusion
DRUGPlacebo
Placebo will be administered as a single 2-hour intravenous infusion
Sponsors
Janssen Pharmaceutical K.K.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
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 76 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events | Up to 76 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed serum CR6261 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 76 or early withdrawal day | — |
| Time to reach the maximum observed serum CR6261 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 76 or early withdrawal day | — |
| Area under the serum CR6261 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 76 or early withdrawal day | — |
| Level of antibodies to CR6261 in serum samples | Day 1 (predose), Day 29, Day 57, Day 76 or early withdrawal day | Level of antibodies to CR6261 in serum samples will evaluate immunogenecity. |
Countries
Japan
Outcome results
None listed