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BMS-981164

Phase 1

Healthy Subjects and Atopic Dermatitis Subjects | Monoclonal antibody | Immunology |Bristol-Myers Squibb Company|Last Updated: Aug 19, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment93

FDA Designations

No designations recorded

Clinical trial landscape

BMS-981164 · 1 trial · 1 indication

Phase 1 1
NCT01614756A Two-Part, Phase 1, Single-Dose Study of IL-31 mAb (Anti-Interleukin 31 Monoclonal Antibody); in Healthy Subjects and Adults With Atopic DermatitisHealthy Subjects and Atopic Dermatitis Subjects
COMPLETED93 Analytics
PHASE1COMPLETED
A Two-Part, Phase 1, Single-Dose Study of IL-31 mAb (Anti-Interleukin 31 Monoclonal Antibody); in Healthy Subjects and Adults With Atopic Dermatitis
Healthy Subjects and Atopic Dermatitis SubjectsUnlock trial analytics

Study Endpoints

Primary Endpoints

For both Part 1 and Part 2, the primary endpoint will be based on incident adverse event reports, vital sign measurements, physical (including injection site) examinations, electrocardiograms (ECGs), medical history, and clinical laboratory tests
Up to 16 weeks after single dose

Secondary Endpoints

The Maximum observed serum concentration (Cmax) of BMS-981164 will be derived from serum concentration versus time
13 timepoints upto 16 weeks after single dose
The Time of maximum observed serum concentration (Tmax) of BMS-981164 will be derived from serum concentration versus time
13 timepoints upto 16 weeks after single dose
The Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-981164 will be derived from serum concentration versus time
13 timepoints upto 16 weeks after single dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose Escalation-BMS-981164 (0.1 mg/kg) or PlaceboEXPERIMENTALPart 1 Single dose of BMS-981164 0.1 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously
Dose Escalation-BMS-981164 (0.01 mg/kg) or PlaceboEXPERIMENTALPart 1 Single dose of BMS-981164 0.01 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously
Dose Escalation-BMS-981164 (0.03 mg/kg) or PlaceboEXPERIMENTALPart 1 Single dose of BMS-981164 0.03 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously
Dose Escalation-BMS-981164 (0.06 mg/kg) or PlaceboEXPERIMENTALPart 1 Single dose of BMS-981164 0.06 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously
Dose Escalation- BMS-981164 (0.1 mg/kg) or PlaceboEXPERIMENTALPart 1 Single dose of BMS-981164 0.1 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously
Dose Escalation-BMS-981164 (0.3 mg/kg) or PlaceboEXPERIMENTALPart 1 Single dose of BMS-981164 0.3 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously
Dose Escalation-BMS-981164 (1 mg/kg SC) or PlaceboEXPERIMENTALPart 1 Single dose of BMS-981164 1 mg/kg solution subcutaneously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously
Dose Escalation-BMS-981164 (1 mg/kg IV) or PlaceboEXPERIMENTALPart 1 Single dose of BMS-981164 1 mg/kg solution intravenously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously
Dose Escalation-BMS-981164 (3 mg/kg IV) or PlaceboEXPERIMENTALPart 1 Single dose of BMS-981164 3 mg/kg solution intravenously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously
Dose Escalation-BMS-981164 (10 mg/kg IV) or PlaceboEXPERIMENTALPart 1 Single dose of BMS-981164 10.0 mg/kg solution intravenously OR Single dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously
Dose Escalation- BMS-981164 or Placebo (dose group 1)EXPERIMENTALPart 2 BMS-981164: Solution, Depending on dose level selected could be subcutaneous or IV, 3 mg/kg, once, single dose OR Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous or IV, 0 mg, once, single dose
Dose Escalation- BMS-981164 or Placebo (dose group 2)EXPERIMENTALPart 2 BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0.1 mg/kg, once, single dose OR Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose
Dose Escalation- BMS-981164 or Placebo (dose group 3)EXPERIMENTALPart 2 BMS-981164: Solution, Depending on dose level selected could be subcutaneous, ≤ 0.1 mg/kg, once, single dose OR Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose
Dose Escalation- BMS-981164 or Placebo (dose group 4)EXPERIMENTALPart 2 BMS-981164: Solution, Depending on dose level selected could be subcutaneous, ≤ 3.0 mg/kg and \>1.0mg/kg, once, single dose OR Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose

Interventions

NameTypeDescription
BMS-981164BIOLOGICAL -
Placebo matching with BMS-981164BIOLOGICAL -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites4

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Part 1: Healthy subjects * Part 2: Adult subjects with: 1. Atopic dermatitis severity as assessed by Physician Global Assessment rating of 3 or higher (i.e., moderate or g...

Countries:United Kingdom
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Frequently asked questions about BMS-981164

What is BMS-981164 used for?

BMS-981164 is an investigational monoclonal antibody being studied for use in healthy subjects and adults with atopic dermatitis. It is being developed by Bristol-Myers Squibb Company (BMY) and is currently in Phase 1 clinical development.

What does BMS-981164 target?

BMS-981164 targets interleukin-31 (IL-31), as indicated by its trial title. It is an anti-interleukin 31 monoclonal antibody designed to bind to this cytokine, which is involved in immune signaling.

Who makes BMS-981164?

BMS-981164 is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY on the stock market. The company is conducting clinical trials to evaluate this investigational monoclonal antibody.

What phase is BMS-981164 in?

BMS-981164 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, with no active trials currently ongoing.

What clinical trials is BMS-981164 in?

BMS-981164 has been studied in one completed Phase 1 clinical trial, identified as NCT01614756. This was a two-part, single-dose study conducted in the United Kingdom, enrolling 93 participants, including healthy subjects and adults with atopic dermatitis.

Is BMS-981164 the same as an IL-31 monoclonal antibody?

BMS-981164 is an anti-interleukin 31 (IL-31) monoclonal antibody. The clinical trial for this drug is titled 'A Two-Part, Phase 1, Single-Dose Study of IL-31 mAb (Anti-Interleukin 31 Monoclonal Antibody)', indicating that BMS-981164 is the IL-31 monoclonal antibody being tested.