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

NCT00925574 | Completed Phase 1

• 2 other identifiers: CR015817CNTO1959PSO1001
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 8

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.

Conditions

Psoriasis

Keywords

CNTO 1959; Healthy Volunteers; Psoriasis

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of CNTO 1959 in healthy volunteers and patients with psoriasis.

  Assessments will occur at each study visit and up to 24 weeks following administration of study agent

Secondary Outcomes (4)

• Pharmacokinetics.

  Assessments will occur at study visits through 24 weeks following administration of study agent.

• Pharmacodynamics

  Assessments will occur at study visits through 24 weeks following administration of study agent.

• Immune Response

  Assessments will occur at study visits through 24 weeks following administration of study agent.

• Clinical Response

  Assessments will occur at study visits through 24 weeks following administration of study agent.

Interventions

CNTO 1959; Placebo DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Centocor, Inc.: lead

Study Sites (8)

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Miramar, Florida, United States

Location

Unknown Facility

Overland Park, Kansas, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Portland, Oregon, United States

Location

Related Links

• Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CNTO 1959 following a Single Intravenous or a Single Subcutaneous Administration in Healthy Subjects and in Subjects with Moderate to Severe Psoriasis

MeSH Terms

Conditions

Psoriasis

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Centocor, Inc. Clinical Trial

  Centocor, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2009
• First Posted: June 22, 2009
• Study Start: June 4, 2009
• Primary Completion: October 11, 2010
• Study Completion: October 11, 2010
• Last Updated: September 5, 2017

Record last verified: 2017-08

Locations

US (8)