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CNTO 7160

Phase 1

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

Target and mechanism

ModalitySmall molecule

Also known as Part 1: CNTO 7160, Part 2 (Asthma): CNTO 7160, Part 2: CNTO 7160

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

Clinical trial landscape

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
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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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