A Study to Assess the Safety, Pharmacokinetics and Immunogenicity of CR6261 in Japanese Healthy Participants

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study in Healthy Japanese Subjects to Assess the Safety, Pharmacokinetics and Immunogenicity of CR6261 Following Single Intravenous Administration

Conditions
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Healthy

Intervention / Treatment
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* Drug: CR6261
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CR6261<br> | Drug: CR6261<br>* CR6261 50 mg/kg solution will be administered as a single 2-hour intravenous infusion<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo will be administered as a single 2-hour intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | Up to 76 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Level of antibodies to CR6261 in serum samples will evaluate immunogenecity. | Day 1 (predose), Day 29, Day 57, Day 76 or early withdrawal day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy, CR6261, Japanese, Safety, Pharmacokinetics, Immunogenicity