Status:
COMPLETED
A Study of the Safety and How the Body Affects a Drug (CNTO 1959) in Healthy Volunteers and in Patients With Psoriasis
Lead Sponsor:
Centocor, Inc.
Conditions:
Psoriasis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and how the body affects a drug (CNTO 1959) in healthy volunteers and in patients with psoriasis.
Detailed Description
CNTO 1959 is an experimental drug. In this study, CNTO 1959 will be tested to see if it may be useful in treating psoriasis. This disease causes inflammation of skin and nails. This is a Randomized (s...
Eligibility Criteria
Inclusion
- Healthy male or female with no clinically significant abnormalities and have a body weight of 50 to 100 kg (Enrollment of healthy volunteers closed on 23SEP09)
- Patients with moderate to severe psoriasis and have a body weight not greater than 120 kg.
Exclusion
- Current or a history of any clinically significant medical illness or medical disorders the investigator considers should exclude the patient, including (but not limited to) cardiovascular disease, neuromuscular, hematological disease, respiratory disease, hepatic or GI disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
- Known or recent history of alcohol or drug abuse
- Major or traumatic surgery within 12 weeks of screening
- Donated blood greater than 500 ml within 56 days of screening
- Pregnant or nursing
- Have recently received phototherapy or any systemic medications/treatments that could affect psoriasis
Key Trial Info
Start Date :
June 4 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2010
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00925574
Start Date
June 4 2009
End Date
October 11 2010
Last Update
September 5 2017
Active Locations (8)
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1
Los Angeles, California, United States
2
San Diego, California, United States
3
Miramar, Florida, United States
4
Overland Park, Kansas, United States