Status:
COMPLETED
A Phase 1 Study of CNTO 3157 in Healthy Volunteers and Patients With Asthma
Lead Sponsor:
Centocor, Inc.
Conditions:
Asthma
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a phase 1, safety study of CNTO 3157 in healthy subjects and subjects with asthma.
Detailed Description
A phase 1, randomized (study drug assigned by chance), double blind (neither physician nor patient knows if CNTO 3157 or placebo has been assigned), placebo controlled, single, ascending-dose study of...
Eligibility Criteria
Inclusion
- Healthy male or female between 18 and 55 years of age inclusive with no clinically significant abnormalities and have a body weight of 50 to 100 kg
- Patients with asthma must have been diagnosed at least 6 months prior to participation in the study
Exclusion
- Currently have or have a history of any clinically significant medical illness or medical disorders the investigator considers should exclude the subject, including (but not limited to) cardiovascular disease, neuromuscular, hematological disease, immune deficiency state, respiratory disease (other than asthma for Part 2), hepatic or GI disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
- Have a positive pregnancy test at screening or prior to dose administration
- Have smoked tobacco or related products within 6 months prior to dosing
- Donated blood equal to or greater than ¿450 mL within 60 days prior to participation in the study
- Recent history (within previous 6 months) of alcohol or drug abuse
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT01195207
Start Date
June 1 2010
End Date
January 1 2012
Last Update
November 27 2012
Active Locations (4)
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1
Antwerp, Belgium
2
Merksem, Belgium
3
Berlin, Germany
4
Harrow, United Kingdom