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CNTO 6785/kg

Phase 1

Healthy | Small molecule | Other |Johnson & Johnson|Last Updated: Jan 28, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

CNTO 6785/kg · 1 trial · 1 indication

Phase 1 1
NCT01288196A Safety, Tolerability, Pharmacokinetics, and Immunogenicity Study of CNTO 6785 in Healthy VolunteersHealthy
COMPLETED32 Analytics
PHASE1COMPLETED
A Safety, Tolerability, Pharmacokinetics, and Immunogenicity Study of CNTO 6785 in Healthy Volunteers
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Study Endpoints

Primary Endpoints

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 Endpoints

Serum concentration of CNTO 6785
Up to Week 17
Serum antibodies to CNTO 6785
Up to Week 17
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
001EXPERIMENTALCNTO 6785 1 mg/kg IV A single 30-minute IV infusion of CNTO 6785 1 mg/kg
002EXPERIMENTALCNTO 6785 3 mg/kg IV A single 30-minute IV infusion of CNTO 6785 3 mg/kg
003EXPERIMENTALCNTO 6785 10 mg/kg IV A single 30-minute IV infusion of CNTO 6785 10 mg/kg
004PLACEBO_COMPARATORPlacebo IV A single 30-minute IV infusion of placebo
005EXPERIMENTALCNTO 6785 SC A single SC dose of CNTO 6785 (3 mg/kg) administered in up to 3 SC injections
006PLACEBO_COMPARATORPlacebo SC A single SC dose of placebo administered in up to 3 SC injections

Interventions

NameTypeDescription
Placebo IVDRUGA single 30-minute IV infusion of placebo
CNTO 6785 1 mg/kg IVDRUGA single 30-minute IV infusion of CNTO 6785 1 mg/kg
CNTO 6785 3 mg/kg IVDRUGA single 30-minute IV infusion of CNTO 6785 3 mg/kg
CNTO 6785 10 mg/kg IVDRUGA single 30-minute IV infusion of CNTO 6785 10 mg/kg
CNTO 6785 SCDRUGA single SC dose of CNTO 6785 (3 mg/kg) administered in up to 3 SC injections
Placebo SCDRUGA single SC dose of placebo administered in up to 3 SC injections
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * 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 su...

Countries:Belgium
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Frequently asked questions about CNTO 6785/kg

What is CNTO 6785 used for?

CNTO 6785 is an investigational small molecule being studied for the treatment of rheumatoid arthritis and moderate to severe chronic obstructive pulmonary disease (COPD). It has also been evaluated in healthy volunteers to assess safety, tolerability, pharmacokinetics, and immunogenicity.

Who makes CNTO 6785?

CNTO 6785 is being developed by Johnson & Johnson (NYSE: JNJ). The company has sponsored clinical trials of the drug in healthy volunteers, rheumatoid arthritis, and chronic obstructive pulmonary disease.

What phase is CNTO 6785 in?

CNTO 6785 has completed Phase 2 clinical trials for rheumatoid arthritis and chronic obstructive pulmonary disease. It also completed a Phase 1 study in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials has CNTO 6785 been in?

CNTO 6785 has been studied in three completed trials. NCT01288196 was a Phase 1 study in healthy volunteers. NCT01909427 was a Phase 2 trial in rheumatoid arthritis patients on methotrexate. NCT01966549 was a Phase 2 trial in moderate to severe COPD patients.

Is CNTO 6785 the same as other drugs?

CNTO 6785 is a distinct investigational compound developed by Johnson & Johnson. No alternative names for this drug have been disclosed in clinical trial records.