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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01081691

Enrollment

Registered

2010-03-05

Start date

2010-02-28

Completion date

2010-09-30

Last updated

2010-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

CNTO 5825, Safety, Phase I, Healthy adults, Healthy Atopic adults

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.

Detailed description

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.

Interventions

BIOLOGICALCNTO 5825

10 mg/kg single dose IV or matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026