A Study Evaluating Intravenous and Subcutaneous Administration of a Human Monoclonal Antibody (CNTO 5825) in Healthy Volunteers
A Randomized, Double-blind, Placebo-controlled, Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CNTO 5825 Following a Single Intravenous or a Single Subcutaneous Administration in Healthy Subjects
2 other identifiers
interventional
64
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Feb 2010
Typical duration for phase_1 healthy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 18, 2010
CompletedFirst Posted
Study publicly available on registry
March 5, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedOctober 1, 2010
September 1, 2010
February 18, 2010
September 30, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
17 weeks post dose
Secondary Outcomes (2)
Evaluate the effects of CNTO5825 on the body and the effects of the body on CNTO 5825 (Pharmacokinetics (PK), Pharmacodynamics (PD))
17 weeks post dose
Immune response (Immunogenicity) after dose with CNTO 5825
17 weeks post dose
Study Arms (7)
001
EXPERIMENTALCNTO 5825 0.1 mg/kg single dose Intravenously (IV) or matching placebo
002
EXPERIMENTALCNTO 5825 0.3 mg/kg single dose IV or matching placebo
003
EXPERIMENTALCNTO 5825 1 mg/kg single dose IV or matching placebo
004
EXPERIMENTALCNTO 5825 3 mg/kg single dose IV or matching placebo
005
EXPERIMENTALCNTO 5825 10 mg/kg single dose IV or matching placebo
006
EXPERIMENTALCNTO 5825 For atopic patient:10 mg/kg single IV dose or matching placebo
007
EXPERIMENTALCNTO 5825 For atopic patient: 3 mg/kg single dose SC or matching placebo
Interventions
Eligibility Criteria
You may qualify if:
- Healthy man or woman with no clinically significant abnormalities
- Body weight in the range of 50 to 100 kg inclusive
- Body mass index (BMI) of 18.5 to 30 kg/m2 inclusive
- For healthy atopic patients: history of atopic allergy
You may not qualify if:
- Known or suspected intolerance or hypersensitivity to any biologic medication or to any components of the formulation used in this study
- Received an experimental antibody or biologic therapy within the previous 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centocor, Inc.lead
Related Publications (1)
van Hartingsveldt B, Nnane IP, Bouman-Thio E, Loza MJ, Piantone A, Davis HM, Petty KJ. Safety, tolerability and pharmacokinetics of a human anti-interleukin-13 monoclonal antibody (CNTO 5825) in an ascending single-dose first-in-human study. Br J Clin Pharmacol. 2013 May;75(5):1289-98. doi: 10.1111/j.1365-2125.2012.04477.x.
PMID: 23043368DERIVED
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Centocor, Inc. Clinical Trial
Centocor, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 18, 2010
First Posted
March 5, 2010
Study Start
February 1, 2010
Study Completion
September 1, 2010
Last Updated
October 1, 2010
Record last verified: 2010-09