Healthy Adult VolunteersPhase 1NCT02079480

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

A Phase 1 study testing BMS-986090 and Keyhole limpet hemocyanin in people with Healthy Adult Volunteers, run by Bristol-Myers Squibb at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Adult Volunteers
What is being tested?: BMS-986090 and Keyhole limpet hemocyanin
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 130 participants
Where: 2 sitesUnited States
Study dates: May 2014to Apr 2016
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

Any significant acute or chronic medical illness

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Parexel Baltimore Early Phase Clinical Unit
Baltimore, Maryland, 21225
California Clinical Trials Medical Group
Glendale, California, 91206

Other trials in United States

About this study

Official title: Double-Blinded, Randomized, Placebo-Controlled, Single Ascending Dose and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986090 in Healthy Subjects

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

Conditions: Healthy Adult Volunteers
Being tested: BMS-986090, Placebo matching with BMS-986090, Keyhole limpet hemocyanin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BMS-986090Drug
Placebo matching with BMS-986090Drug
Keyhole limpet hemocyaninDrug
Also called KLH

Study groups in NCT02079480
Study group	Role	What they receive
Panel 1: BMS-986090 (0.5 mg) or Placebo	Experimental	BMS-986090 0.5 mg solution single dose subcutaneously once OR Placebo matching with BMS-986090 0 mg solution single dose subcutaneously once Receives: Drug: BMS-986090; Drug: Placebo matching with BMS-986090
Panel 2: BMS-986090 (3 mg) or Placebo	Experimental	BMS-986090 3 mg solution single dose subcutaneously once OR Placebo matching with BMS-986090 0 mg solution single dose subcutaneously once Receives: Drug: BMS-986090; Drug: Placebo matching with BMS-986090
Panel 3: BMS-986090 (10 mg) or Placebo	Experimental	BMS-986090 10 mg solution single dose subcutaneously once OR Placebo matching with BMS-986090 0 mg solution single dose subcutaneously once Receives: Drug: BMS-986090; Drug: Placebo matching with BMS-986090
Panel 4: BMS-986090 (30 mg) or Placebo + KLH (1 mg)	Experimental	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 Receives: Drug: BMS-986090; Drug: Placebo matching with BMS-986090; Drug: Keyhole limpet hemocyanin
Panel 5: BMS-986090 (100 mg) or Placebo + KLH (1 mg)	Experimental	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 Receives: Drug: BMS-986090; Drug: Placebo matching with BMS-986090; Drug: Keyhole limpet hemocyanin
Panel 6: BMS-986090 (100 mg) or Placebo	Experimental	BMS-986090 100 mg solution single dose intravenously once OR Placebo matching with BMS-986090 0 mg solution single dose intravenously once Receives: Drug: BMS-986090; Drug: Placebo matching with BMS-986090
Panel 7: BMS-986090 (300 mg) or Placebo + KLH (1 mg)	Experimental	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 Receives: Drug: BMS-986090; Drug: Placebo matching with BMS-986090; Drug: Keyhole limpet hemocyanin
Panel 8: BMS-986090 (750 mg) or Placebo	Experimental	BMS-986090 750 mg solution single dose intravenously once OR Placebo matching with BMS-986090 0 mg solution single dose intravenously once Receives: Drug: BMS-986090; Drug: Placebo matching with BMS-986090
Panel 9: BMS-986090 (150 mg) or Placebo	Experimental	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 Receives: Drug: BMS-986090; Drug: Placebo matching with BMS-986090

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and tolerability of single dose measured by incidence, potential significance and clinical importance of AEs, as determined by medical review of AE reports, vital sign measurements, ECGs and results of physical examination and laboratory tests
AE = Adverse event
ECG = Electrocardiogram
Measured: Up to Day 85 after single dose of BMS-986090
Safety and tolerability of multiple dose measured by incidence, potential significance and clinical importance of AEs, as determined by medical review of AE reports, vital sign measurements, ECGs and results of physical examination and laboratory tests
Measured: Up to Day 106 after multiple dose of BMS-986090

Secondary outcomes (24)

Maximum observed serum concentration (Cmax) of BMS-986090 single dose subcutaneous (SC) and intravenous (IV)
Measured: Days 1 -85
Time of maximum observed serum concentration (Tmax) of single dose BMS-986090 SC and IV
Measured: Days 1 -85
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of single dose BMS-986090 SC and IV
Measured: Days 1 -85
Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of single dose BMS-986090 SC and IV
Measured: Days 1 -85
Terminal serum half-life (T-HALF) of single dose BMS-986090 SC and IV
Measured: Days 1 -85
Total body clearance (CLT) of single dose BMS-986090 IV
Measured: Days 1 -85
Apparent total body clearance (CLT/F) of single dose BMS-986090 SC
Measured: Days 1 -85
Volume of distribution at terminal phase (Vz) of single dose BMS-986090 IV
Measured: Days 1 -85
Volume of distribution during steady state (Vss) of single dose BMS-986090 IV
Measured: Days 1 -85
Apparent volume of distribution at terminal phase (Vz/F) of single dose BMS-986090 SC
Measured: Days 1 -85
Absolute bioavailability (F) of single dose BMS-986090 SC
Measured: Days 1 -85
Maximum observed serum concentration (Cmax) of multiple dose BMS-986090 SC
Measured: Days 1 -106
Time of maximum observed serum concentration (Tmax) of multiple dose BMS-986090 SC
Measured: Days 1 -106
Terminal serum half-life (T-HALF) of multiple dose BMS-986090 SC
Measured: Days 1 -106
Area under the serum concentration-time curve in one dosing Interval [AUC(TAU)] of multiple dose BMS-986090 SC
Measured: Days 1 -106
Trough observed plasma concentration (Ctrough) of multiple dose BMS-986090 SC
Measured: Days 1 -106
Average concentration over a dosing interval (Css-avg) of multiple dose BMS-986090 SC
Measured: Days 1 -106
Degree of Fluctuation (DF) of multiple dose BMS-986090 SC
Measured: Days 1 -106
AUC accumulation index (AI_AUC); ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose of BMS-986090 SC (multiple dose)
Measured: Days 1 -106
Cmax accumulation index (AI_Cmax); ratio of Cmax at steady state to Cmax after the first dose of BMS-986090 SC (multiple dose)
Measured: Days 1 -106
Apparent total body clearance (CLT/F) of multiple dose BMS-986090 SC
Measured: Days 1 -106
Anti-KLH immunoglobulin G (IgG) and IgM antibody levels of single dose BMS-986090 SC
Measured: Days 1 -85
Immunogenicity of BMS-986090 following single SC / IV infusion measured by frequency of subjects with positive anti-drug-antibody (ADA) assessment and frequency of subjects who develop positive ADA following a negative baseline
Measured: Days 1 -85
Receptor occupancy (RO) of BMS-986090 following single SC or IV infusion
Measured: Days 1 -85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014Apr 2016

First posted5 Mar 2014 (estimated)
Study startMay 2014
Primary completionApr 2016
Study completionApr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy Adult VolunteersStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02079480
Sponsor's protocol ID: IM142-003
Status last verified: May 2016
First submitted: 4 Mar 2014
Last updated: 12 May 2016
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy Adult Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Double-Blinded, Randomized, Placebo-Controlled, Single Ascending Dose and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986090 in Healthy Subjects
ClinicalTrials.gov ID: NCT02079480
Acronym / sponsor ID: IM142-003
Conditions: Healthy Adult Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Terminated
Enrolment: 130 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: May 2014
Primary completion: Apr 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 5 Mar 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 9

Arm	Type	Receives
Panel 1: BMS-986090 (0.5 mg) or Placebo	Experimental	Drug: BMS-986090, Drug: Placebo matching with BMS-986090BMS-986090 0.5 mg solution single dose subcutaneously once OR Placebo matching with BMS-986090 0 mg solution single dose subcutaneously once
Panel 2: BMS-986090 (3 mg) or Placebo	Experimental	Drug: BMS-986090, Drug: Placebo matching with BMS-986090BMS-986090 3 mg solution single dose subcutaneously once OR Placebo matching with BMS-986090 0 mg solution single dose subcutaneously once
Panel 3: BMS-986090 (10 mg) or Placebo	Experimental	Drug: BMS-986090, Drug: Placebo matching with BMS-986090BMS-986090 10 mg solution single dose subcutaneously once OR Placebo matching with BMS-986090 0 mg solution single dose subcutaneously once
Panel 4: BMS-986090 (30 mg) or Placebo + KLH (1 mg)	Experimental	Drug: BMS-986090, Drug: Placebo matching with BMS-986090, Drug: Keyhole limpet hemocyaninBMS-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
Panel 5: BMS-986090 (100 mg) or Placebo + KLH (1 mg)	Experimental	Drug: BMS-986090, Drug: Placebo matching with BMS-986090, Drug: Keyhole limpet hemocyaninBMS-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
Panel 6: BMS-986090 (100 mg) or Placebo	Experimental	Drug: BMS-986090, Drug: Placebo matching with BMS-986090BMS-986090 100 mg solution single dose intravenously once OR Placebo matching with BMS-986090 0 mg solution single dose intravenously once
Panel 7: BMS-986090 (300 mg) or Placebo + KLH (1 mg)	Experimental	Drug: BMS-986090, Drug: Placebo matching with BMS-986090, Drug: Keyhole limpet hemocyaninBMS-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
Panel 8: BMS-986090 (750 mg) or Placebo	Experimental	Drug: BMS-986090, Drug: Placebo matching with BMS-986090BMS-986090 750 mg solution single dose intravenously once OR Placebo matching with BMS-986090 0 mg solution single dose intravenously once
Panel 9: BMS-986090 (150 mg) or Placebo	Experimental	Drug: BMS-986090, Drug: Placebo matching with BMS-986090BMS-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

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

Any significant acute or chronic medical illness

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BMS-986090	Drug	Panel 1: BMS-986090 (0.5 mg) or Placebo, Panel 2: BMS-986090 (3 mg) or Placebo, Panel 3: BMS-986090 (10 mg) or Placebo, Panel 4: BMS-986090 (30 mg) or Placebo + KLH (1 mg), Panel 5: BMS-986090 (100 mg) or Placebo + KLH (1 mg), Panel 6: BMS-986090 (100 mg) or Placebo, Panel 7: BMS-986090 (300 mg) or Placebo + KLH (1 mg), Panel 8: BMS-986090 (750 mg) or Placebo, Panel 9: BMS-986090 (150 mg) or Placebo
Placebo matching with BMS-986090	Drug	Panel 1: BMS-986090 (0.5 mg) or Placebo, Panel 2: BMS-986090 (3 mg) or Placebo, Panel 3: BMS-986090 (10 mg) or Placebo, Panel 4: BMS-986090 (30 mg) or Placebo + KLH (1 mg), Panel 5: BMS-986090 (100 mg) or Placebo + KLH (1 mg), Panel 6: BMS-986090 (100 mg) or Placebo, Panel 7: BMS-986090 (300 mg) or Placebo + KLH (1 mg), Panel 8: BMS-986090 (750 mg) or Placebo, Panel 9: BMS-986090 (150 mg) or Placebo
Keyhole limpet hemocyaninAlso: KLH	Drug	Panel 4: BMS-986090 (30 mg) or Placebo + KLH (1 mg), Panel 5: BMS-986090 (100 mg) or Placebo + KLH (1 mg), Panel 7: BMS-986090 (300 mg) or Placebo + KLH (1 mg)

Primary outcome

Safety and tolerability of single dose measured by incidence, potential significance and clinical importance of AEs, as determined by medical review of AE reports, vital sign measurements, ECGs and results of physical examination and laboratory tests
Time frame: Up to Day 85 after single dose of BMS-986090
AE = Adverse event ECG = Electrocardiogram
Safety and tolerability of multiple dose measured by incidence, potential significance and clinical importance of AEs, as determined by medical review of AE reports, vital sign measurements, ECGs and results of physical examination and laboratory tests
Time frame: Up to Day 106 after multiple dose of BMS-986090

24 secondary outcomes

Maximum observed serum concentration (Cmax) of BMS-986090 single dose subcutaneous (SC) and intravenous (IV)
Time frame: Days 1 -85
Time of maximum observed serum concentration (Tmax) of single dose BMS-986090 SC and IV
Time frame: Days 1 -85
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of single dose BMS-986090 SC and IV
Time frame: Days 1 -85
Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of single dose BMS-986090 SC and IV
Time frame: Days 1 -85
Terminal serum half-life (T-HALF) of single dose BMS-986090 SC and IV
Time frame: Days 1 -85
Total body clearance (CLT) of single dose BMS-986090 IV
Time frame: Days 1 -85
Apparent total body clearance (CLT/F) of single dose BMS-986090 SC
Time frame: Days 1 -85
Volume of distribution at terminal phase (Vz) of single dose BMS-986090 IV
Time frame: Days 1 -85
Volume of distribution during steady state (Vss) of single dose BMS-986090 IV
Time frame: Days 1 -85
Apparent volume of distribution at terminal phase (Vz/F) of single dose BMS-986090 SC
Time frame: Days 1 -85
Absolute bioavailability (F) of single dose BMS-986090 SC
Time frame: Days 1 -85
Maximum observed serum concentration (Cmax) of multiple dose BMS-986090 SC
Time frame: Days 1 -106
Time of maximum observed serum concentration (Tmax) of multiple dose BMS-986090 SC
Time frame: Days 1 -106
Terminal serum half-life (T-HALF) of multiple dose BMS-986090 SC
Time frame: Days 1 -106
Area under the serum concentration-time curve in one dosing Interval [AUC(TAU)] of multiple dose BMS-986090 SC
Time frame: Days 1 -106
Trough observed plasma concentration (Ctrough) of multiple dose BMS-986090 SC
Time frame: Days 1 -106
Average concentration over a dosing interval (Css-avg) of multiple dose BMS-986090 SC
Time frame: Days 1 -106
Degree of Fluctuation (DF) of multiple dose BMS-986090 SC
Time frame: Days 1 -106
AUC accumulation index (AI_AUC); ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose of BMS-986090 SC (multiple dose)
Time frame: Days 1 -106
Cmax accumulation index (AI_Cmax); ratio of Cmax at steady state to Cmax after the first dose of BMS-986090 SC (multiple dose)
Time frame: Days 1 -106
Apparent total body clearance (CLT/F) of multiple dose BMS-986090 SC
Time frame: Days 1 -106
Anti-KLH immunoglobulin G (IgG) and IgM antibody levels of single dose BMS-986090 SC
Time frame: Days 1 -85
Immunogenicity of BMS-986090 following single SC / IV infusion measured by frequency of subjects with positive anti-drug-antibody (ADA) assessment and frequency of subjects who develop positive ADA following a negative baseline
Time frame: Days 1 -85
Receptor occupancy (RO) of BMS-986090 following single SC or IV infusion
Time frame: Days 1 -85

Results and safety

The study was stopped early. Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BMS-986090 and Keyhole limpet hemocyanin in people with Healthy Adult Volunteers, run by Bristol-Myers Squibb at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability of single dose measured by incidence, potential significance and clinical importance of AEs, as determined by medical review of AE reports, vital sign measurements, ECGs and results of physical examination and laboratory tests (time frame: Up to Day 85 after single dose of BMS-986090). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02079480.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.