MedDataX Logo

Study to Evaluate the Safety, Tolerability, PK, and PD of BMS-986090 in Healthy Subjects

NCT ID: NCT02079480

Last Updated: 2016-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BMS-986090 in healthy subjects.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Evaluate the Safety, Pharmacokinetics and Target Engagement of BMS-986142 in Healthy Subjects

NCT02257151

Healthy Adult
COMPLETED PHASE1

A Randomized, Double Blind Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects

NCT02790125

Healthy
COMPLETED PHASE1

A Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Target Engagement of BMS-986147 in Healthy Subjects

NCT02293629

Healthy
COMPLETED PHASE1

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986325 in Healthy Japanese Participants

NCT05813717

Healthy Volunteers
COMPLETED PHASE1

A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986454 in Healthy Participants

NCT06086886

Healthy Participants
COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Adult Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Panel 6: BMS-986090 (100 mg) or Placebo

BMS-986090 100 mg solution single dose intravenously once

OR

Placebo matching with BMS-986090 0 mg solution single dose intravenously once

Group Type EXPERIMENTAL

BMS-986090

Intervention Type DRUG

Placebo matching with BMS-986090

Intervention Type DRUG

Panel 7: BMS-986090 (300 mg) or Placebo + KLH (1 mg)

BMS-986090 300 mg solution single dose subcutaneously once

OR

Placebo matching with BMS-986090 0 mg solution single dose subcutaneously once

And KLH 1 mg solution single intramuscular dose once

Group Type EXPERIMENTAL

BMS-986090

Intervention Type DRUG

Placebo matching with BMS-986090

Intervention Type DRUG

Keyhole limpet hemocyanin

Intervention Type DRUG

Panel 8: BMS-986090 (750 mg) or Placebo

BMS-986090 750 mg solution single dose intravenously once

OR

Placebo matching with BMS-986090 0 mg solution single dose intravenously once

Group Type EXPERIMENTAL

BMS-986090

Intervention Type DRUG

Placebo matching with BMS-986090

Intervention Type DRUG

Panel 9: BMS-986090 (150 mg) or Placebo

BMS-986090 150 mg solution subcutaneously once weekly for 4 weeks

OR

Placebo matching with BMS-986090 0 mg solution subcutaneously once weekly for 4 weeks

Group Type EXPERIMENTAL

BMS-986090

Intervention Type DRUG

Placebo matching with BMS-986090

Intervention Type DRUG

Panel 1: BMS-986090 (0.5 mg) or Placebo

BMS-986090 0.5 mg solution single dose subcutaneously once

OR

Placebo matching with BMS-986090 0 mg solution single dose subcutaneously once

Group Type EXPERIMENTAL

BMS-986090

Intervention Type DRUG

Placebo matching with BMS-986090

Intervention Type DRUG

Panel 2: BMS-986090 (3 mg) or Placebo

BMS-986090 3 mg solution single dose subcutaneously once

OR

Placebo matching with BMS-986090 0 mg solution single dose subcutaneously once

Group Type EXPERIMENTAL

BMS-986090

Intervention Type DRUG

Placebo matching with BMS-986090

Intervention Type DRUG

Panel 3: BMS-986090 (10 mg) or Placebo

BMS-986090 10 mg solution single dose subcutaneously once

OR

Placebo matching with BMS-986090 0 mg solution single dose subcutaneously once

Group Type EXPERIMENTAL

BMS-986090

Intervention Type DRUG

Placebo matching with BMS-986090

Intervention Type DRUG

Panel 4: BMS-986090 (30 mg) or Placebo + KLH (1 mg)

BMS-986090 30 mg solution single dose subcutaneously once

OR

Placebo matching with BMS-986090 0 mg solution single dose subcutaneously once

And Keyhole limpet hemocyanin (KLH) 1 mg solution single intramuscular dose once

Group Type EXPERIMENTAL

BMS-986090

Intervention Type DRUG

Placebo matching with BMS-986090

Intervention Type DRUG

Keyhole limpet hemocyanin

Intervention Type DRUG

Panel 5: BMS-986090 (100 mg) or Placebo + KLH (1 mg)

BMS-986090 100 mg solution single dose subcutaneously once

OR

Placebo matching with BMS-986090 0 mg solution single dose subcutaneously once

And KLH 1 mg solution single intramuscular dose once

Group Type EXPERIMENTAL

BMS-986090

Intervention Type DRUG

Placebo matching with BMS-986090

Intervention Type DRUG

Keyhole limpet hemocyanin

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BMS-986090

Intervention Type DRUG

Placebo matching with BMS-986090

Intervention Type DRUG

Keyhole limpet hemocyanin

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

KLH

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy male and female (of not childbearing potential), ages 18-45 years, inclusive
* BMI 18 to 32 kg/m2, inclusive

Exclusion Criteria

\- Any significant acute or chronic medical illness
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

California Clinical Trials Medical Group

Glendale, California, United States

Site Status

Parexel Baltimore Early Phase Clinical Unit

Baltimore, Maryland, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IM142-003

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986447 in Healthy Participants
NCT05760937 COMPLETED PHASE1
A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986278 in Healthy Chinese Participants
NCT05805904 COMPLETED PHASE1
A Phase 1, First-in-Human Study of BMS-986421 in Healthy Participants
NCT05517837 TERMINATED EARLY_PHASE1
Randomized, Placebo-Controlled, Double-Blind, Ascending Single and Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-963272 in Healthy Subjects
NCT02327273 COMPLETED PHASE1
Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986331 in Healthy Participants
NCT04444050 COMPLETED PHASE1
Study With Healthy Japanese and Non-Asian Participants With BMS-986231
NCT02932969 COMPLETED PHASE1
A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986446 in Healthy Participants and Healthy Participants of Japanese Ethnicity
NCT06084598 COMPLETED PHASE1
A Single and Multiple Ascending Dose Study of BMS-986318 in Healthy Participants
NCT04082741 WITHDRAWN PHASE1
Placebo-Controlled, Single and Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986089 in Healthy Adult Subjects
NCT02145234 COMPLETED PHASE1
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986521 in Healthy Participants.
NCT07283263 RECRUITING PHASE1
A Single-dose Study to Evaluate the Safety, Tolerability, Drug Levels, and Relative Biological Availability of Alternate Formulations of BMS-986460 in Healthy Adult Male Participants
NCT06877702 COMPLETED PHASE1
A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese Descent
NCT05546151 COMPLETED PHASE1
A Short and Long Intravenous Infusion Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-962212 in Healthy Subjects
NCT03197779 COMPLETED PHASE1
An Ascending Dose Study of BMS-986259 to Study Safety in Healthy Participants
NCT04008992 COMPLETED PHASE1
A Study of Experimental Medication BMS-986278 Given to Healthy Participants
NCT03429933 COMPLETED PHASE1
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986166 in Healthy Japanese Participants
NCT04965402 COMPLETED PHASE1
A Study to Test the Effects of BMS-986036 on the Body in Healthy Japanese and Non-Japanese Subjects
NCT03198182 COMPLETED PHASE1
A Study of Experimental Medication BMS-986235 in Healthy Subjects
NCT03335553 COMPLETED PHASE1
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Healthy Participants
NCT04736134 COMPLETED PHASE1
An Investigational Study to Evaluate the Effects of Experimental Medication BMS-986256 in Healthy Participants
NCT03634995 COMPLETED PHASE1
Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-933043 in Healthy Subjects
NCT01605994 COMPLETED PHASE1
Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986141 in Healthy Subjects
NCT02341638 COMPLETED PHASE1
Single and Multiple Dose Pharmacokinetics of BMS-986165 in a Randomized, Double-Blind, Placebo-Controlled Study in Healthy Chinese Subjects
NCT03956953 COMPLETED PHASE1
A Study to Evaluate the Safety, Tolerability, and Drug Levels of Danicamtiv in Healthy Japanese and Caucasian Participants
NCT05806359 COMPLETED PHASE1
Evaluation of the Pharmacokinetics and Safety of BLU-5937 in Healthy Adult Japanese and Caucasian Subjects
NCT06179537 COMPLETED PHASE1