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CNTO 7160

Phase 1

Asthma | Small molecule | Respiratory |Johnson & Johnson|Trials Updated: Nov 16, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment108

FDA Designations

No designations recorded

CNTO 7160 clinical trials

CNTO 7160 · 1 trial · 3 indications

Phase 1 1
NCT02345928A Single Ascending Dose Study in Healthy Participants and Multiple Ascending Dose Study of CNTO 7160 in Participants With Asthma and Participants With Atopic DermatitisAsthma
COMPLETED108 Analytics
PHASE1COMPLETED
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
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of CNTO 7160 (Part 1)
Through Week 17

The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.

Number of Participants with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability of CNTO 7160 (Part 2)
Through Week 21

The incidence of TEAEs from treatment until the last scheduled follow-up visit will be summarized by treatment group.

Secondary Endpoints

Maximum Observed Serum Concentration (Cmax) (Part 1)
Up to Week 17 after dose
Maximum Observed Serum Concentration (Cmax) (Part 2)
Up to Week 21 after dose
Area Under the Serum Time Curve [AUC(0-t) and AUC(0-infinity)] (Part 1)
Up to Week 17 after dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: Dose 1EXPERIMENTALDrug CNTO7160 or Placebo administered IV infusion Dose 1.
Part 1: Dose 2EXPERIMENTALDrug CNTO7160 or Placebo administered IV infusion Dose 2.
Part 1: Dose 3EXPERIMENTALDrug CNTO7160 or Placebo administered IV infusion Dose 3.
Part 1: Dose 4EXPERIMENTALDrug CNTO7160 or Placebo administered IV infusion Dose 4.
Part 1: Dose 5EXPERIMENTALDrug CNTO7160 or Placebo administered IV infusion Dose 5.
Part 1: Dose 6EXPERIMENTALDrug CNTO7160 or Placebo administered IV infusion Dose 6.
Part 1: Dose 7EXPERIMENTALDrug CNTO7160 or Placebo administered IV infusion Dose 7.
Part 1: Dose 8EXPERIMENTALDrug CNTO7160 or Placebo administered IV infusion Dose 8.
Part 1: Dose 9EXPERIMENTALDrug CNTO7160 or Placebo administered IV infusion Dose 9.
Part 2 (Asthma): Dose 1EXPERIMENTALDrug CNTO 7160 or Placebo administered IV infusions Dose 1 (3 dose administrations over 4 weeks).
Part 2 (Asthma): Dose 2EXPERIMENTALDrug CNTO 7160 or Placebo administered IV infusions Dose 2 (3 dose administrations over 4 weeks).
Part 2 (Atopic Dermatitis): Dose 1EXPERIMENTALDrug CNTO 7160 or Placebo administered IV infusions Dose 1 (3 dose administrations over 4 weeks).
Part 2 (Atopic Dermatitis): Dose 2EXPERIMENTALDrug CNTO 7160 or Placebo administered IV infusions Dose 2 (3 dose administrations over 4 weeks).

Interventions

NameTypeDescription
Part 1: CNTO 7160DRUGParticipants will receive Drug CNTO7160 administered IV infusion at escalating doses (with a starting dose of 0.001 mg/kg).
Part 2 (Asthma): CNTO 7160DRUGParticipants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks).
Part 2 (Atopic Dermatitis): CNTO 7160DRUGParticipants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks).
Part 1 and Part 2: PlaceboDRUGParticipants will receive single IV infusion of placebo matched to CNTO 7160.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites7

Inclusion Criteria: * Part 1 (Healthy Participants): Participant must have a body weight in the range of 50 to 100 kilogram (kg) inclusive and have a body mass index (BMI) of 19 to 30 kilogram per meter square (kg/m\^2) inclusive * Part 1 (Healthy Participants): Participant must be healthy on the b...

Countries:BelgiumGermany
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Frequently asked questions about CNTO 7160

What is CNTO 7160 used for?

CNTO 7160 is an investigational small molecule being studied for the treatment of asthma, a respiratory condition. It was also evaluated in a clinical trial that included participants with atopic dermatitis. CNTO 7160 has not been approved for any indication and remains in clinical development.

Who is developing CNTO 7160?

CNTO 7160 is being developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored the clinical trial that evaluated the drug in healthy participants, participants with asthma, and participants with atopic dermatitis.

What phase is CNTO 7160 in?

CNTO 7160 is in Phase 1 clinical development. The single trial conducted for this drug was a Phase 1 study, and it has been completed. CNTO 7160 is investigational and has not received FDA approval for asthma or any other indication.

What clinical trial is CNTO 7160 in?

CNTO 7160 was evaluated in one completed Phase 1 trial, NCT02345928. The study was a single ascending dose study in healthy participants and a multiple ascending dose study in participants with asthma and participants with atopic dermatitis. It enrolled 108 participants across Belgium and Germany.

Is CNTO 7160 the same as Part 1: CNTO 7160, Part 2 (Asthma): CNTO 7160, or Part 2: CNTO 7160?

Yes. CNTO 7160 is also referred to as Part 1: CNTO 7160, Part 2 (Asthma): CNTO 7160, and Part 2: CNTO 7160. These names refer to the same investigational drug developed by Johnson & Johnson for asthma and related conditions.