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
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
- Asthma
- Atopic Dermatitis
- Healthy
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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