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BMS-981164

Phase 1

Undisclosed | Monoclonal antibody | Immunology |Bristol-Myers Squibb Company|Trials Updated: Aug 19, 2015

BMS-981164 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jun 2012

BMS-981164 target and mechanism

ModalityMonoclonal antibody

Also known as IL-31 mAB

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

BMS-981164 clinical trials

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?

BMS-981164 is an investigational monoclonal antibody developed by Bristol-Myers Squibb Company (ticker BMY). It was studied as an anti-interleukin 31 monoclonal antibody in a Phase 1 clinical trial that enrolled healthy volunteers and adults with atopic dermatitis. The study has been completed, and the program remains in early-stage clinical development.

What does BMS-981164 target?

BMS-981164 targets interleukin 31, or IL-31. It is an anti-interleukin 31 monoclonal antibody, meaning it is designed to bind IL-31. The Phase 1 study of BMS-981164 was titled as a study of an IL-31 monoclonal antibody in healthy subjects and adults with atopic dermatitis.

Who makes BMS-981164?

Bristol-Myers Squibb Company, which trades under the ticker BMY, is the developer of BMS-981164. The company sponsored the Phase 1 study of the anti-interleukin 31 monoclonal antibody conducted in the United Kingdom.

What phase is BMS-981164 in?

BMS-981164 is in Phase 1 development. It is an investigational monoclonal antibody and is not described as approved. Its only recorded trial, NCT01614756, was a Phase 1 study that has been completed, and no active trials are currently listed for the asset.

What clinical trials is BMS-981164 in?

BMS-981164 was evaluated in one clinical trial, NCT01614756, titled a two-part Phase 1 single-dose study of an IL-31 monoclonal antibody in healthy subjects and adults with atopic dermatitis. The trial was completed, enrolled 93 participants, was randomized, double-blind, and controlled, and was conducted in the United Kingdom.