Recent Updates
Recently added Catalysts

BMS-986089

Phase 1

Healthy Adults | Small molecule | Other |Roche Holding AG|Last Updated: Sep 7, 2017

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment140

FDA Designations

No designations recorded

Clinical trial landscape

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 Adults
NCT02145234140
Unlock 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
Unlock Study Endpoints

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 -
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about BMS-986089

What is BMS-986089 used for?

BMS-986089 is an investigational small molecule being studied in healthy adults. It is being evaluated for safety, tolerability, pharmacokinetics, and pharmacodynamics. The drug is not approved for any indication and is in early clinical development.

Who makes BMS-986089?

BMS-986089 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The drug is currently in Phase 1 clinical development.

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 regulatory authorities. A Phase 1 study has been completed in healthy adult subjects.

What clinical trials is BMS-986089 in?

BMS-986089 has one completed clinical trial, NCT02145234. This was a placebo-controlled, single and multiple ascending subcutaneous dose study evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy adults. The trial enrolled 140 participants in the United States.

Is BMS-986089 FDA approved?

BMS-986089 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial in healthy adults. The drug remains in clinical development and has not been approved for any use.