Clinical trial NCT02016066: A Study to Assess the Safety, Pharmacokinetics and Immunogenicity of CR6261 in Japanese Healthy Participants
Official title: A Randomized, Double-Blind, Placebo-Controlled Study in Healthy Japanese Subjects to Assess the Safety, Pharmacokinetics and Immunogenicity of CR6261 Following Single Intravenous Administration
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
CR6261
Japanese
Safety
Pharmacokinetics
Immunogenicity
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2013-12-19
Enrollment: 0
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: Up to 76 days
Secondary outcomes:
measure: Maximum observed serum CR6261 concentration
timeFrame: 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
measure: Time to reach the maximum observed serum CR6261 concentration
timeFrame: 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
measure: Area under the serum CR6261 concentration-time curve
timeFrame: 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
measure: Level of antibodies to CR6261 in serum samples
timeFrame: Day 1 (predose), Day 29, Day 57, Day 76 or early withdrawal day
Other outcomes:
Locations:
city: Osaka
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: