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BMS-962476

Phase 1

Atherosclerosis | Monoclonal antibody | Cardiovascular |Bristol-Myers Squibb Company|Last Updated: Sep 4, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment66

FDA Designations

No designations recorded

Clinical trial landscape

BMS-962476 · 1 trial · 1 indication

Phase 1 1
NCT01587365Single Ascending Dose Safety Study of BMS-962476 in Healthy Subjects and Patients With Elevated Cholesterol on StatinsAtherosclerosis
COMPLETED66 Analytics
PHASE1COMPLETED
Single Ascending Dose Safety Study of BMS-962476 in Healthy Subjects and Patients With Elevated Cholesterol on Statins
AtherosclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of BMS-962476 as measured by the number of subjects with serious adverse events, deaths or discontinuations due to adverse events (AEs), AEs of injection site reactions, or potentially clinically significant changes in vital signs
Up to Day 43

Secondary Endpoints

Pharmacodynamic effects of single subcutaneous (SC) and intravenous (IV) doses of BMS-962476
Up to Day 43
Maximum observed plasma concentration (Cmax) of single dose pharmacokinetics (PK) and dose proportionality of BMS-962476 following SC and IV administration
17 time points up to Day 43
Time of maximum observed plasma concentration (Tmax) of single dose pharmacokinetics (PK) and dose proportionality of BMS-962476 following SC and IV administration
17 time points up to Day 43
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Panel 1: BMS-962476 SC (0.01 mg/Kg) or PlaceboEXPERIMENTALBMS-962476 0.01 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day
Panel 2: BMS-962476 SC (0.03 mg/Kg) or PlaceboEXPERIMENTALBMS-962476 0.03 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day
Panel 3: BMS-962476 SC (0.1 mg/Kg) or PlaceboEXPERIMENTALBMS-962476 0.1 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day
Panel 4: BMS-962476 SC (0.3 mg/Kg) or PlaceboEXPERIMENTALBMS-962476 0.3 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day
Panel 5: BMS-962476 IV (0.3 mg/Kg) or PlaceboEXPERIMENTALBMS-962476 0.3 mg/kg or Placebo matching with BMS-962476 0 mg liquid intravenously (IV), Single Dose, 1 day
Panel 6: BMS-962476 IV (1.0 mg/Kg) or PlaceboEXPERIMENTALBMS-962476 1.0 mg/kg or Placebo matching with BMS-962476 0 mg liquid intravenously (IV), Single Dose, 1 day
Panel 7: Statin + BMS-962476 SC (0.1 mg/Kg) or PlaceboEXPERIMENTALBMS-962476 0.1 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day
Panel 8: Statin + BMS-962476 SC (0.3 mg/Kg) or PlaceboEXPERIMENTALBMS-962476 0.3 mg/kg or Placebo matching with BMS-962476 0 mg liquid subcutaneously (SC), Single Dose, 1 day

Interventions

NameTypeDescription
BMS-962476BIOLOGICAL -
Placebo matching with BMS-962476BIOLOGICAL -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy population * Untreated low density lipoprotein cholesterol (LDL-c) ≥ 130 and ≤ 190 mg/dL and triglycerides ≤ 200 mg/dL * Body Mass Index (BMI) of 18 to 35 kg/m2 inclusive * Men and women, ages 18 to 65 years, inclusive * Statin population * Patients with hype...

Countries:United States
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Frequently asked questions about BMS-962476

What is BMS-962476 used for?

BMS-962476 is an investigational monoclonal antibody being developed for the treatment of atherosclerosis, a condition characterized by the buildup of plaque in the arteries. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who is developing BMS-962476?

BMS-962476 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol BMY. The drug is in Phase 1 clinical development for the treatment of atherosclerosis.

What phase is BMS-962476 in?

BMS-962476 is in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. The drug is being studied for its safety and tolerability in patients with elevated cholesterol and atherosclerosis.

What clinical trials is BMS-962476 in?

BMS-962476 has one completed Phase 1 clinical trial, identified as NCT01587365. This was a single ascending dose safety study conducted in healthy subjects and patients with elevated cholesterol on statins. The trial enrolled 66 participants and was conducted in the United States.

Is BMS-962476 the same as any other drug?

BMS-962476 is a distinct investigational monoclonal antibody developed by Bristol-Myers Squibb. It is not known to be the same as any other marketed drug. It is being studied specifically for its potential role in treating atherosclerosis.