A Phase 1 interventional study of Part 1: CNTO 7160 and Part 2 (Asthma): CNTO 7160 in Asthma, Atopic Dermatitis and Healthy, sponsored by Janssen Research & Development, LLC. Completed at 7 sites in 2 countries. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-16.
Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Treatment
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.
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.
3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.
This study's enrollment of 108 is above the median of 83 across 2,751 interventional studies indexed under Asthma.
Browse Asthma studies →Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.
Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug CNTO7160 or Placebo administered IV infusion Dose 1.
Drug: Part 1: CNTO 7160 · Drug: Part 1 and Part 2: Placebo
Drug CNTO7160 or Placebo administered IV infusion Dose 2.
Drug: Part 1: CNTO 7160 · Drug: Part 1 and Part 2: Placebo
Drug CNTO7160 or Placebo administered IV infusion Dose 3.
Drug: Part 1: CNTO 7160 · Drug: Part 1 and Part 2: Placebo
Drug CNTO7160 or Placebo administered IV infusion Dose 4.
Drug: Part 1: CNTO 7160 · Drug: Part 1 and Part 2: Placebo
Drug CNTO7160 or Placebo administered IV infusion Dose 5.
Drug: Part 1: CNTO 7160 · Drug: Part 1 and Part 2: Placebo
Drug CNTO7160 or Placebo administered IV infusion Dose 6.
Drug: Part 1: CNTO 7160 · Drug: Part 1 and Part 2: Placebo
Drug CNTO7160 or Placebo administered IV infusion Dose 7.
Drug: Part 1: CNTO 7160 · Drug: Part 1 and Part 2: Placebo
Drug CNTO7160 or Placebo administered IV infusion Dose 8.
Drug: Part 1: CNTO 7160 · Drug: Part 1 and Part 2: Placebo
Drug CNTO7160 or Placebo administered IV infusion Dose 9.
Drug: Part 1: CNTO 7160 · Drug: Part 1 and Part 2: Placebo
Drug CNTO 7160 or Placebo administered IV infusions Dose 1 (3 dose administrations over 4 weeks).
Drug: Part 2 (Asthma): CNTO 7160 · Drug: Part 1 and Part 2: Placebo
Drug CNTO 7160 or Placebo administered IV infusions Dose 2 (3 dose administrations over 4 weeks).
Drug: Part 2 (Asthma): CNTO 7160 · Drug: Part 1 and Part 2: Placebo
Drug CNTO 7160 or Placebo administered IV infusions Dose 1 (3 dose administrations over 4 weeks).
Drug: Part 2 (Atopic Dermatitis): CNTO 7160 · Drug: Part 1 and Part 2: Placebo
Drug CNTO 7160 or Placebo administered IV infusions Dose 2 (3 dose administrations over 4 weeks).
Drug: Part 2 (Atopic Dermatitis): CNTO 7160 · Drug: Part 1 and Part 2: Placebo
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.
Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of CNTO 7160 (Part 1)
The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.
Time frame: Through Week 17
Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of CNTO 7160 (Part 2)
The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.
Time frame: Through Week 21
Maximum Observed Serum Concentration (Cmax) (Part 1)
Cmax (microgram per millileter \[mcg/mL\]) will be summarized by treatment group.
Time frame: Up to Week 17 after dose
Maximum Observed Serum Concentration (Cmax) (Part 2)
Cmax (mcg/mL) after the first and last dose will be summarized by treatment group.
Time frame: Up to Week 21 after dose
Area Under the Serum Time Curve [AUC(0-t) and AUC(0-infinity)] (Part 1)
AUC (mcg\*day/mL) will be summarized by treatment group.
Time frame: Up to Week 17 after dose
Area Under the Serum Concentration Versus Time Curve [AUC(t1-t2)] (Part 2)
AUC (mcg\*day/mL) will be summarized by treatment group.
Time frame: Up to Week 21 after dose
Number of Participants With Antibodies to CNTO 7160 (Part 1)
The incidence of participants with anti-CNTO 7160 antibodies will be summarized by treatment group.
Time frame: Up to Week 17
Number of Participants with Antibodies to CNTO 7160 (Part 2)
The incidence of participants with anti-CNTO 7160 antibodies will be summarized by treatment group.
Time frame: Up to Week 21
Change From Baseline in Immunoglobulin E (IgE) (Part 2)
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) (Part 2)
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, Week 21
Change From Baseline in Forced Expiratory Volume in 1 second (FEV1) in Participants With Asthma
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
Change From Baseline in Eczema Area Severity Index (EASI) in Participants With Atopic Dermatitis
Changes in EASI score from baseline through the end of follow up will be summarized by treatment group.
Time frame: Baseline up to week 21
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Janssen Research & Development, LLC