A Phase 1 interventional study of CNTO 5825 and CNTO 5825 in Healthy, sponsored by Centocor, Inc.. Completed. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-10-01.
Sponsored by Centocor, Inc. · Phase 1, Interventional, and Treatment
The purpose of this study is to assess the safety and tolerability of CNTO 5825 following a single intravenous (IV) or subcutaneous (SC) dose administration in healthy volunteers.
This is a randomized (study medication assigned by chance), placebo controlled, double-blind (neither physician or subject knows the name of the assigned study medication) study to assess the safety, tolerability, immune response, pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of CNTO 5825. The study population will consist of 48 healthy volunteers and 16 healthy atopic volunteers. Five dose levels of study agent will be assessed. Participants will be required to stay at the research center after study agent administration for the inpatient portion of the study and then return for out-patient visits. Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events. Placebo (containing inactive substances only) or one of five dose levels of CNTO 5825 will be given. Healthy volunteers will be given a single IV infusion (directly into a vein) or a single dose of up to 3 injections under the skin. Healthy atopic volunteers will be given one dose as as an IV infusion. There will be a screening period of up to 4 weeks. All participants will be in the study for 17 weeks after dose administration.
Centocor, Inc. is the lead sponsor of 73 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
CNTO 5825 0.1 mg/kg single dose Intravenously (IV) or matching placebo
Biological: CNTO 5825
CNTO 5825 0.3 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
CNTO 5825 1 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
CNTO 5825 3 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
CNTO 5825 10 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
CNTO 5825 For atopic patient:10 mg/kg single IV dose or matching placebo
Biological: CNTO 5825
CNTO 5825 For atopic patient: 3 mg/kg single dose SC or matching placebo
Biological: CNTO 5825
10 mg/kg single dose IV or matching placebo
3 mg/kg single dose IV or matching placebo
For atopic patient:10 mg/kg single IV dose or matching placebo
For atopic patient: 3 mg/kg single dose SC or matching placebo
0.3 mg/kg single dose IV or matching placebo
0.1 mg/kg single dose Intravenously (IV) or matching placebo
1 mg/kg single dose IV or matching placebo
Safety and tolerability of CNTO 5825 by evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events in healthy volunteers.
Time frame: 17 weeks post dose
Evaluate the effects of CNTO5825 on the body and the effects of the body on CNTO 5825 (Pharmacokinetics (PK), Pharmacodynamics (PD))
Time frame: 17 weeks post dose
Immune response (Immunogenicity) after dose with CNTO 5825
Time frame: 17 weeks post dose
No study locations are listed for this record.
This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.
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Centocor, Inc.