Part 1: CNTO 7160
DrugParticipants will receive Drug CNTO7160 administered IV infusion at escalating doses (with a starting dose of 0.001 mg/kg).
NCT Number: NCT02345928
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.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Antwerp, Belgium
This is a Phase 1, randomized, placebo-controlled, multicenter study of CNTO 7160. The study consists of Screening Period, In-patient period (6 days for healthy participants, 11 days for asthmatic participants and atopic dermatitis participants) and outpatient period (105 days for healthy participants, 110 days for asthmatic and atopic dermatitis participants). The total duration of participation for each participant will be approximately 21 weeks for healthy participants, 25 weeks for asthmatic participants, and atopic dermatitis participants. All eligible participants will be randomly assigned to receive active agent or placebo. The study will be conducted in 2 parts. In Part 1, single ascending doses of CNTO 7160 or placebo will be administered to sequential cohorts of healthy participants as an IV infusion. In Part 2, ascending multiple doses of CNTO 7160 or placebo will be administered as IV infusions to sequential cohorts of participants with asthma or atopic dermatitis. Blood samples will be collected for assessment of pharmacokinetic and pharmacodynamics parameters in both part 1 and 2 parameters, along with assessment of safety and clinical effects in part 2. Participants' safety will be monitored throughout the study.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive Drug CNTO7160 administered IV infusion at escalating doses (with a starting dose of 0.001 mg/kg).
Participants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks).
Participants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks).
Participants will receive single IV infusion of placebo matched to CNTO 7160.
Time frame: Through Week 17
The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.
Time frame: Through Week 21
The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.
Time frame: Up to Week 17 after dose
Cmax (microgram per millileter [mcg/mL]) will be summarized by treatment group.
Time frame: Up to Week 21 after dose
Cmax (mcg/mL) after the first and last dose will be summarized by treatment group.
Time frame: Up to Week 17 after dose
AUC (mcg*day/mL) will be summarized by treatment group.
Time frame: Up to Week 21 after dose
AUC (mcg*day/mL) will be summarized by treatment group.
Time frame: Up to Week 17
The incidence of participants with anti-CNTO 7160 antibodies will be summarized by treatment group.
Time frame: Up to Week 21
The incidence of participants with anti-CNTO 7160 antibodies will be summarized by treatment group.
Time frame: Baseline, Week 21
Change from Baseline in immunoglobulin E (IgE) Concentration (international unit per millileter [IU/mL]) through Week 21 will be summarized by treatment group.
Time frame: Baseline, Week 21
Change from Baseline in Chemokine (C-C motif) Ligand 17 (CCL17) concentration (picogram per millileter [pg/mL]) through Week 21 will be summarized by treatment group.
Time frame: Baseline Up to week 21
Changes in FEV1 (liter [L]) from baseline through end of follow up will be summarized by treatment group.
Time frame: Baseline up to week 21
Changes in EASI score from baseline through the end of follow up will be summarized by treatment group.
Janssen Research & Development, LLC
Industry
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study in Healthy Subjects and Multiple Ascending Dose Study of CNTO 7160 in Subjects With Asthma and Subjects With Atopic Dermatitis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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