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Healthy AdultsPhase 1NCT02145234

Placebo-Controlled, Single and Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986089 in Healthy Adult Subjects

A Phase 1 study testing BMS-986089 in people with Healthy Adults, run by Hoffmann-La Roche at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of single and multiple doses of BMS-986089 in healthy adult subjects. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Adults
What is being tested?
BMS-986089
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
140 participants
Where
1 siteUnited States
Study dates
30 Jun 2014to 29 Feb 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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy subjects as determined by no clinically significant deviation from normal medical history, physical examination, ECGs and clinical laboratory determinations
  • Men and women who are not of childbearing potential (ie, who are postmenopausal or Surgically sterile WOCBP) ages 21 to 55 years
  • Women must not be breastfeeding
  • Men who are sexually active with women of child bearing potential (WOCBP) must use any contraceptive method with a failure rate of less than 1% per year

Who cannot join

  • Any significant acute or chronic medical illness Any major surgery within 6 weeks of study drug administration
  • Any condition that will clearly require medical or surgical treatment during the period of study participation
  • Any bone trauma or bone surgery within 3 months of study drug administration
  • Known or suspected autoimmune disorder
  • Donation of blood or plasma to a blood bank or in a clinical study (except at screening visit) within 6 weeks of study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wcct Global, Llc

    Cypress, California, 90630

Other trials in United States

About this study

Official title: A Randomized, Placebo-Controlled, Single and Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986089 in Healthy Adult Subjects

The purpose of this study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of single and multiple doses of BMS-986089 in healthy adult subjects.

Read the detailed description

Primary Purpose - other: Protocol designed to assess the safety, tolerability, immunogenicity, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BMS-986089 in healthy subjects

Enrollment: Single ascending dose panels: 48 subjects, Multiple ascending dose panels: 96

Minimum age: 18 years (Elderly MAD Panel 65 years of age) Maximum age: 55 years (Elderly MAD Panel 70 years of age)

Conditions
Healthy Adults
Being tested
BMS-986089, Placebo matching with BMS-986089

What participants receive

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

  • BMS-986089Drug

  • Placebo matching with BMS-986089Drug

Study groups in NCT02145234
Study groupRoleWhat they receive
SAD Panel 1:BMS-986089/PlaceboExperimentalBMS-986089 in a single subcutaneous administration OR Placebo matching with BMS-986089 in a single subcutaneous administration
Receives: Drug: BMS-986089; Drug: Placebo matching with BMS-986089
SAD Panel 2:BMS-986089/PlaceboExperimentalBMS-986089 in a single subcutaneous administration OR Placebo matching with BMS-986089 in a single subcutaneous administration
Receives: Drug: BMS-986089; Drug: Placebo matching with BMS-986089
SAD Panel 3:BMS-986089/PlaceboExperimentalBMS-986089 in a single subcutaneous administration OR Placebo matching with BMS-986089 in a single subcutaneous administration
Receives: Drug: BMS-986089; Drug: Placebo matching with BMS-986089
SAD Panel 4:BMS-986089/PlaceboExperimentalBMS-986089 in a single subcutaneous administration OR Placebo matching with BMS-986089 in a single subcutaneous administration
Receives: Drug: BMS-986089; Drug: Placebo matching with BMS-986089
SAD Panel 5:BMS-986089/PlaceboExperimentalBMS-986089 in a single subcutaneous administration OR Placebo matching with BMS-986089 in a single subcutaneous administration
Receives: Drug: BMS-986089; Drug: Placebo matching with BMS-986089
MAD Panel 1:BMS-986089/PlaceboExperimentalBMS-986089 in multiple subcutaneous administrations weekly OR Placebo matching with BMS-986089 multiple subcutaneous administrations weekly
Receives: Drug: BMS-986089; Drug: Placebo matching with BMS-986089
MAD Panel 2:BMS-986089/PlaceboExperimentalBMS-986089 in multiple subcutaneous administrations weekly OR Placebo matching with BMS-986089 in multiple subcutaneous administrations weekly
Receives: Drug: BMS-986089; Drug: Placebo matching with BMS-986089
MAD Panel 3:BMS-986089/PlaceboExperimentalBMS-986089 in multiple subcutaneous administrations weekly OR Placebo matching with BMS-986089 in multiple subcutaneous administrations weekly
Receives: Drug: BMS-986089; Drug: Placebo matching with BMS-986089
MAD Panel 4:BMS-986089/PlaceboExperimentalBMS-986089 in multiple subcutaneous administrations weekly OR Placebo matching with BMS-986089 in multiple subcutaneous administrations weekly
Receives: Drug: BMS-986089; Drug: Placebo matching with BMS-986089
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
Receives: Drug: BMS-986089; Drug: Placebo matching with BMS-986089
MAD Panel 6:BMS-986089/PlaceboExperimentalBMS-986089 in multiple subcutaneous administrations weekly OR Placebo matching with BMS-986089 in multiple subcutaneous administrations weekly
Receives: Drug: BMS-986089; Drug: Placebo matching with BMS-986089
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
Receives: Drug: BMS-986089; Drug: Placebo matching with BMS-986089

What is being measured

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

  1. 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

    Measured: Single Ascending Dose (SAD) Phase 119 days

  2. 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

    Measured: Multiple Ascending Dose (MAD) phase 148 days

Secondary outcomes (19)

  1. Maximum observed serum concentration (Cmax) for SAD and MAD

    Measured: SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120

  2. Time of maximum observed serum concentration (Tmax) for SAD and MAD

    Measured: SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120

  3. Serum concentration 168 h post dose (C(168H)) for SAD and MAD

    Measured: SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120

  4. Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) for SAD

    Measured: SAD phase: Day1 to Day 91

  5. Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) for SAD

    Measured: SAD phase: Day1 to Day 91

  6. Apparent total body clearance (CLT/F) for SAD

    Measured: SAD phase: Day1 to Day 91

  7. Volume of distribution of terminal phase (if IV and if multi-exponential decline) (Vz/F) for SAD

    Measured: SAD phase: Day1 to Day 91

  8. Half life (T-Half) for SAD and MAD

    Measured: SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120

  9. Serum concentration 336 h post dose (C(336H)) for SAD and MAD

    Measured: SAD phase: Day1 to Day 91, MAD phase: Day 1 to Day 120

  10. Effective elimination half-life that explains the degree of AUC accumulation observed (T-HALFeff_AUC) for MAD

    Measured: MAD phase: Day 1 to Day 120

  11. Area under the concentration-time curve in one dosing interval (AUC(TAU)) for MAD

    Measured: MAD phase: Day 1 to Day 120

  12. Degree of Fluctuation or Fluctuation Index (DF) for MAD

    Measured: MAD phase: Day 1 to Day 120

  13. Average concentration over a dosing interval (Css-Avg) for MAD

    Measured: MAD phase: Day 1 to Day 120

  14. AUC Accumulation Index; ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI AUC) for MAD

    Measured: MAD phase: Day 1 to Day 120

  15. Cmax Accumulation Index; ratio of Cmax at steady-state to Cmax after the first dose (AI Cmax) for MAD

    Measured: MAD phase: Day 1 to Day 120

  16. C(168H) Accumulation Index; ratio of C168H at steady-state to C168H after the first dose (AI C168H) for MAD

    Measured: MAD phase: Day 1 to Day 120

  17. C(336H) Accumulation Index; ratio of C(336H) at steady-state to C(336H) after the first dose (AI 336H) for MAD

    Measured: MAD phase: Day 1 to Day 120

  18. Immunogenicity of single and multiple doses of BMS-986089 will be measured by testing for the presence of ADAs for SAD and MAD

    Measured: 30 days

  19. The pharmacodynamic effect of single and multiple doses of BMS-986089 on free myostatin, total myostatin (pre-dose only), and myostatin-drug complex will be assessed by measuring these biomarkers for SAD and MAD

    Measured: 30 days

Timeline

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

  1. First posted22 May 2014 (estimated)
  2. Study start30 Jun 2014
  3. Primary completion29 Feb 2016
  4. Study completion29 Feb 2016

Resources

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
Other
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02145234
Sponsor's protocol ID
CN001-001
Status last verified
Sep 2017
First submitted
16 May 2014
Last updated
7 Sep 2017
Results posted
No
Data monitoring committee
No

Publications

  • Muntoni F, Byrne BJ, McMillan HJ, Ryan MM, Wong BL, Dukart J, Bansal A, Cosson V, Dreghici R, Guridi M, Rabbia M, Staunton H, Tirucherai GS, Yen K, Yuan X, Wagner KR; Taldefgrobep Alfa Study Group. The Clinical Development of Taldefgrobep Alfa: An Anti-Myostatin Adnectin for the Treatment of Duchenne Muscular Dystrophy. Neurol Ther. 2024 Feb;13(1):183-219. doi: 10.1007/s40120-023-00570-w. Epub 2024 Jan 8.

    PubMed 38190001

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BMS-986089 in people with Healthy Adults, run by Hoffmann-La Roche at 1 site 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 4 inclusion and 5 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 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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 (time frame: Single Ascending Dose (SAD) Phase 119 days). 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 NCT02145234, which also lists 1 linked publication.

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 7 Sep 2017.

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