Liver Fibrosis/NASHPhase 1NCT02538874
A Study of BMS-986171 in Healthy People to Assess Safety, to Measure Blood Levels of Drug, and to Find Out What the Drug Does to the Body
A Phase 1 study testing BMS-986171 in people with Liver Fibrosis/NASH, run by Bristol-Myers Squibb at 2 sites in United States.
Trial summary
The purpose of this study is to assess safety, to measure blood levels of drug, and to find out what the drug does to the body. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Fibrosis/NASH
- What is being tested?
- BMS-986171
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 275 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Oct 2015to 5 Nov 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 21 to 55 years (Part A,B, and C)
- BMI 30-40 (Part A or Part B); BMI 20-35 (Part C). BMI = weight (kg)/ [height (m)]
Who cannot join
- Any significant medical illness
- Cannot tolerate subcutaneous injections, or having blood samples taken
- Smoking more than 10 cigarettes/day
- History of allergy to pegylated compounds or of hypersensitivity to protein based therapeutics.
- HIV, Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection.
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Profil Institute For Clinical Research, Inc.
Chula Vista, California, 91911
Wcct Global, Llc
Cypress, California, 90630
About this study
Official title: A Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986171 in Healthy Subjects
The purpose of this study is to assess safety, to measure blood levels of drug, and to find out what the drug does to the body.
- Conditions
- Liver Fibrosis/NASH
- Being tested
- BMS-986171, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986171Drug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Part A: Single Ascending Dose (SAD) | Experimental | BMS-986171 or Placebo on specified days Receives: Drug: BMS-986171; Other: Placebo |
| Part B: Multiple Ascending Dose (MAD) | Experimental | BMS-986171 or Placebo on specified days Receives: Drug: BMS-986171; Other: Placebo |
| Part C: Multiple Ascending Dose in Japanese subjects (J-MAD) | Experimental | BMS-986171 or Placebo on specified days Receives: Drug: BMS-986171; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of single dose of BMS-986171 will be measured by number of incidence of AEs, serious AEs, and events of special interest including injection site assessment, AEs leading to discontinuation
Adverse Event (AE)
Measured: up to 30 days after the last dose
Safety and tolerability of multiple subcutaneous doses of BMS-986171 will be measured by number of incidence of AEs, serious AEs, and events of special interest including injection site assessment, AEs leading to discontinuation
Measured: up to 30 days after the last dose
Safety and tolerability of single dose of BMS-986171 will be measured by number of incidence of Death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, physical examinations
Measured: up to 30 days after the last dose
Safety and tolerability of multiple subcutaneous doses of BMS-986171 will be measured by number of incidence of Death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, physical examinations
Measured: up to 30 days after the last dose
Secondary outcomes (1)
Immunogenicity based on antibody responses
Measured: 6 months following study discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study start31 Oct 2015
- Primary completion4 Nov 2016
- Study completion5 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Fibrosis/NASHStudies 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, Investigator, Outcomes assessor
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538874
- Sponsor's protocol ID
- MB007-005
- Status last verified
- May 2017
- First submitted
- 21 Aug 2015
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986171 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02538874
- Acronym / sponsor ID
- MB007-005
- Conditions
- Liver Fibrosis/NASH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2015 (actual)
- Primary completion
- 4 Nov 2016 (actual)
- Study completion
- 5 Nov 2016 (actual)
- First posted
- 2 Sep 2015 (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 assess safety, to measure blood levels of drug, and to find out what the drug does to the body.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A: Single Ascending Dose (SAD) | Experimental | Drug: BMS-986171, Other: PlaceboBMS-986171 or Placebo on specified days |
| Part B: Multiple Ascending Dose (MAD) | Experimental | Drug: BMS-986171, Other: PlaceboBMS-986171 or Placebo on specified days |
| Part C: Multiple Ascending Dose in Japanese subjects (J-MAD) | Experimental | Drug: BMS-986171, Other: PlaceboBMS-986171 or Placebo on specified days |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 21 to 55 years (Part A,B, and C)
- BMI 30-40 (Part A or Part B); BMI 20-35 (Part C). BMI = weight (kg)/ [height (m)]
Key exclusion criteria (6 listed)
- Any significant medical illness
- Cannot tolerate subcutaneous injections, or having blood samples taken
- Smoking more than 10 cigarettes/day
- History of allergy to pegylated compounds or of hypersensitivity to protein based therapeutics.
- HIV, Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection.
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-986171 | Drug | Part A: Single Ascending Dose (SAD), Part B: Multiple Ascending Dose (MAD), Part C: Multiple Ascending Dose in Japanese subjects (J-MAD) |
| Placebo | Other | Part A: Single Ascending Dose (SAD), Part B: Multiple Ascending Dose (MAD), Part C: Multiple Ascending Dose in Japanese subjects (J-MAD) |
Primary outcome
Safety and tolerability of single dose of BMS-986171 will be measured by number of incidence of AEs, serious AEs, and events of special interest including injection site assessment, AEs leading to discontinuation
Time frame: up to 30 days after the last dose
Adverse Event (AE)
Safety and tolerability of multiple subcutaneous doses of BMS-986171 will be measured by number of incidence of AEs, serious AEs, and events of special interest including injection site assessment, AEs leading to discontinuation
Time frame: up to 30 days after the last dose
Safety and tolerability of single dose of BMS-986171 will be measured by number of incidence of Death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, physical examinations
Time frame: up to 30 days after the last dose
Safety and tolerability of multiple subcutaneous doses of BMS-986171 will be measured by number of incidence of Death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, physical examinations
Time frame: up to 30 days after the last dose
1 secondary outcome
Immunogenicity based on antibody responses
Time frame: 6 months following study discharge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
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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-986171 in people with Liver Fibrosis/NASH, 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 6 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: finished, as of the sponsor's last update on 24 May 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of BMS-986171 will be measured by number of incidence of AEs, serious AEs, and events of special interest including injection site assessment, AEs leading to discontinuation (time frame: up to 30 days after the last dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2017.