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BMS-986089

Phase 1

Undisclosed | Small molecule | Other |Roche Holding AG|Trials Updated: Sep 7, 2017

BMS-986089 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since May 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment140

FDA Designations

No designations recorded

BMS-986089 clinical trials

BMS-986089 · 1 trial · 1 indication

Phase 1 1
NCT02145234Placebo-Controlled, Single and Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986089 in Healthy Adult SubjectsHealthy Adults
COMPLETED140 Analytics
PHASE1COMPLETED
Placebo-Controlled, Single and Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986089 in Healthy Adult Subjects
Healthy AdultsUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety endpoints, including incidence of Adverse Event (AEs), serious AEs, AEs leading to discontinuation or death, as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, and physical examinations
Single Ascending Dose (SAD) Phase 119 days

Secondary Endpoints

Maximum observed serum concentration (Cmax) for SAD and MAD
SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120
Time of maximum observed serum concentration (Tmax) for SAD and MAD
SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120
Serum concentration 168 h post dose (C(168H)) for SAD and MAD
SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
SAD Panel 1:BMS-986089/PlaceboEXPERIMENTALBMS-986089 in a single subcutaneous administration OR Placebo matching with BMS-986089 in a single subcutaneous administration
SAD Panel 2:BMS-986089/PlaceboEXPERIMENTALBMS-986089 in a single subcutaneous administration OR Placebo matching with BMS-986089 in a single subcutaneous administration
SAD Panel 3:BMS-986089/PlaceboEXPERIMENTALBMS-986089 in a single subcutaneous administration OR Placebo matching with BMS-986089 in a single subcutaneous administration
SAD Panel 4:BMS-986089/PlaceboEXPERIMENTALBMS-986089 in a single subcutaneous administration OR Placebo matching with BMS-986089 in a single subcutaneous administration
SAD Panel 5:BMS-986089/PlaceboEXPERIMENTALBMS-986089 in a single subcutaneous administration OR Placebo matching with BMS-986089 in a single subcutaneous administration
MAD Panel 1:BMS-986089/PlaceboEXPERIMENTALBMS-986089 in multiple subcutaneous administrations weekly OR Placebo matching with BMS-986089 multiple subcutaneous administrations weekly
MAD Panel 2:BMS-986089/PlaceboEXPERIMENTALBMS-986089 in multiple subcutaneous administrations weekly OR Placebo matching with BMS-986089 in multiple subcutaneous administrations weekly
MAD Panel 3:BMS-986089/PlaceboEXPERIMENTALBMS-986089 in multiple subcutaneous administrations weekly OR Placebo matching with BMS-986089 in multiple subcutaneous administrations weekly
MAD Panel 4:BMS-986089/PlaceboEXPERIMENTALBMS-986089 in multiple subcutaneous administrations weekly OR Placebo matching with BMS-986089 in multiple subcutaneous administrations weekly
MAD Panel 5:BMS-986089/PlaceboEXPERIMENTALBMS-986089 in multiple subcutaneous administration every 2 weeks OR Placebo matching with BMS-986089 in multiple subcutaneous administrations weekly
MAD Panel 6:BMS-986089/PlaceboEXPERIMENTALBMS-986089 in multiple subcutaneous administrations weekly OR Placebo matching with BMS-986089 in multiple subcutaneous administrations weekly
MAD Panel 7:BMS-986089/PlaceboEXPERIMENTALBMS-986089 a single subcutaneous administrations weekly OR Placebo matching with BMS-986089 a single subcutaneous administration every 2 weeks

Interventions

NameTypeDescription
BMS-986089DRUG -
Placebo matching with BMS-986089DRUG -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Healthy subjects as determined by no clinically significant deviation from normal medical history, physical examination, ECGs and clinical laboratory determinations * Men and...

Countries:United States
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Frequently asked questions about BMS-986089

What is BMS-986089?

BMS-986089 is an investigational small molecule developed by Roche Holding AG. It has been studied in a Phase 1 clinical trial in healthy adult volunteers. The specific disease indications for BMS-986089 have not been disclosed, and the compound remains in early clinical development.

Who is developing BMS-986089?

BMS-986089 is being developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche holds the development program for this small molecule asset.

What phase is BMS-986089 in?

BMS-986089 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed, and no trials are currently active.

What clinical trials has BMS-986089 been studied in?

BMS-986089 was evaluated in a single Phase 1 trial, NCT02145234, titled a placebo-controlled, single and multiple ascending subcutaneous dose study of safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy adult subjects. The trial enrolled 140 participants in the United States, was randomized, double-blind, and controlled, and is now completed.

What is BMS-986089 used for?

BMS-986089 has been studied in healthy adult volunteers rather than in patients with a specific disease. Its intended therapeutic indications have not been disclosed, so no approved or investigational use in a particular condition can be stated.

How was BMS-986089 administered in its clinical trial?

BMS-986089 was given by subcutaneous injection in its Phase 1 trial, NCT02145234. That study tested single and multiple ascending doses against placebo in 140 healthy adult subjects to assess safety, tolerability, pharmacokinetics, and pharmacodynamics.