A Single Ascending Dose Study in Healthy Participants and Multiple Ascending Dose Study of CNTO 7160 in Participants With Asthma and Participants With Atopic Dermatitis

NCT02345928 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2020-11-16

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and tolerability of single ascending dose of CNTO 7160 administered intravenously (IV) in healthy participants and multiple dose administered IV in participants with asthma and atopic dermatitis.

Conditions

Interventions

DRUG

Part 1: CNTO 7160

Participants will receive Drug CNTO7160 administered IV infusion at escalating doses (with a starting dose of 0.001 mg/kg).

DRUG

Part 2 (Asthma): CNTO 7160

Participants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks).

DRUG

Part 2 (Atopic Dermatitis): CNTO 7160

Participants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks).

DRUG

Part 1 and Part 2: Placebo

Participants will receive single IV infusion of placebo matched to CNTO 7160.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-05
Primary Completion
2017-03-16
Completion
2017-03-16

Countries

  • Belgium
  • Germany

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02345928 on ClinicalTrials.gov