A Randomized, Double-Blind, Placebo-Controlled Study in Healthy Japanese Subjects to Assess the Safety, Pharmacokinetics and Immunogenicity of CR6261 Following Single Intravenous Administration
Overview
- Phase
- Phase 1
- Intervention
- CR6261
- Conditions
- Healthy
- Sponsor
- Janssen Pharmaceutical K.K.
- Primary Endpoint
- Number of participants with adverse events
- Status
- Withdrawn
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
CR6261
Intervention: CR6261
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Number of participants with adverse events
Time Frame: Up to 76 days
Secondary Outcomes
- 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)
- Level of antibodies to CR6261 in serum samples(Day 1 (predose), Day 29, Day 57, Day 76 or early withdrawal day)
- 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)