NCT01288196

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, blood levels, and immune responses of CNTO 6785 after administration to healthy adult volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Feb 2011

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

January 28, 2013

Status Verified

January 1, 2013

Enrollment Period

6 months

First QC Date

February 1, 2011

Last Update Submit

January 25, 2013

Conditions

Healthy

Keywords

CNTO 6785IntravenousSubcutaneousPharmacokineticsImmunogenicitySafetyTolerability

Outcome Measures

Primary Outcomes (5)

  • Number and type of adverse events reported

    Up to Week 17

  • Number and type of Infusion (injection) site reactions

    Up to Week 17

  • Vital signs measurements

    Up to Week 17

  • Clinical laboratory test results

    Up to Week 17

  • Findings from cardiology assessments (electrocardiograms [ECGs] and cardiac telemetry)

    Up to Week 17

Secondary Outcomes (2)

  • Serum concentration of CNTO 6785

    Up to Week 17

  • Serum antibodies to CNTO 6785

    Up to Week 17

Study Arms (6)

001

EXPERIMENTAL

CNTO 6785 1 mg/kg IV A single 30-minute IV infusion of CNTO 6785 1 mg/kg

Drug: CNTO 6785 1 mg/kg IV

002

EXPERIMENTAL

CNTO 6785 3 mg/kg IV A single 30-minute IV infusion of CNTO 6785 3 mg/kg

Drug: CNTO 6785 3 mg/kg IV

003

EXPERIMENTAL

CNTO 6785 10 mg/kg IV A single 30-minute IV infusion of CNTO 6785 10 mg/kg

Drug: CNTO 6785 10 mg/kg IV

004

PLACEBO COMPARATOR

Placebo IV A single 30-minute IV infusion of placebo

Drug: Placebo IV

005

EXPERIMENTAL

CNTO 6785 SC A single SC dose of CNTO 6785 (3 mg/kg) administered in up to 3 SC injections

Drug: CNTO 6785 SC

006

PLACEBO COMPARATOR

Placebo SC A single SC dose of placebo administered in up to 3 SC injections

Drug: Placebo SC

Interventions

Placebo IVDRUG

A single 30-minute IV infusion of placebo

004
CNTO 6785 1 mg/kg IVDRUG

A single 30-minute IV infusion of CNTO 6785 1 mg/kg

001
CNTO 6785 3 mg/kg IVDRUG

A single 30-minute IV infusion of CNTO 6785 3 mg/kg

002
CNTO 6785 10 mg/kg IVDRUG

A single 30-minute IV infusion of CNTO 6785 10 mg/kg

003
CNTO 6785 SCDRUG

A single SC dose of CNTO 6785 (3 mg/kg) administered in up to 3 SC injections

005
Placebo SCDRUG

A single SC dose of placebo administered in up to 3 SC injections

006

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult volunteer with no clinically significant abnormalities as determined by the investigator (study physician)
  • Have a body mass index (BMI) between 19-30 kg/m2
  • Be a non-smoker for at least 6 months prior to study participation
  • Women must be postmenopausal or surgically sterile

You may not qualify if:

  • Currently have or have a history of any clinically significant medical illness or medical disorders (includes malignancies or serious infections) that the investigator (study physician) considers should exclude the volunteer from the study
  • Major surgery or significant trauma within 12 weeks of screening
  • Any volunteer who plans to undergo elective surgery within 4 weeks prior to study agent administration and through the end of the study
  • Consumes, on average, more than approximately 500 mg/day of caffeine (as contained in 5 cups of tea or coffee or 8 cans of soda or other caffeinated products per day).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Merksem, Belgium

Location

Study Officials

  • Janssen-Cilag International NV Clinical Trial

    Janssen-Cilag International NV

    STUDY DIRECTOR

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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2011

First Posted

February 2, 2011

Study Start

February 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

January 28, 2013

Record last verified: 2013-01

Locations

BE(1)