Status:
COMPLETED
Safety, Tolerability and Pharmacodynamic Activity of JNJ-26528398 in Healthy Male Participants
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy Participants
Eligibility:
MALE
18-35 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the anti-inflammatory properties of JNJ-26528398 using an intravenous (IV) endotoxin-induced model of acute, transient inflammation.
Detailed Description
This is a 2-part, single center, double-blind study (neither physician nor participant knows the treatment that the participant receives). Part 1 is designed to evaluate the safety, tolerability, and ...
Eligibility Criteria
Inclusion
- Nonsmoker
- Be in good health on the basis of physical examination, medical history, and electrocardiogram (ECG)
- Must have good exercise tolerance
- Have a body mass index of 18-29 kg/m2, inclusive, and body weight between 60 and 85 kg, inclusive
- Have a history of consistent dental hygiene and dental care
- Must adhere to required contraception (subject and partner, if applicable) during the study and for 3 months after study
- Must agree to not donate sperm during the study and for 3 months after study
Exclusion
- Is currently enrolled in an investigational study, has recently received an investigational drug (including investigational vaccines), or has donated blood within 3 months
- Has had a vaccination within past 3 months
- Has history of significant drug or alcohol abuse within past 2 years or has a positive drug screen
- Blood donation within past 3 months
- Part 2 only: Has received endotoxin within past 3 months, or has a known allergy or history of significant adverse reaction to endotoxin or its excipients lactose and polyethylene glycol 6000
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01520142
Start Date
November 1 2011
End Date
April 1 2012
Last Update
June 24 2013
Active Locations (1)
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1
Antwerp, Belgium