A Study of the Safety and How the Body Affects a Drug (CNTO 1959) in Healthy Volunteers and in Patients With Psoriasis

Completed · Phase 1 · Has a placebo group

Conditions studied: Psoriasis

In brief

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.

Key facts

Study ID

NCT00925574

Run by

Centocor, Inc.

People needed

71

Starts

2009-06-04

Expected to finish

2010-10-11

Last updated by the study team

2017-09-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Study site — Los Angeles, California, United States
• Study site — San Diego, California, United States
• Study site — Miramar, Florida, United States
• Study site — Overland Park, Kansas, United States
• Study site — Baltimore, Maryland, United States
• Study site — St Louis, Missouri, United States
• Study site — New York, New York, United States
• Study site — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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