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A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04736134
Recruitment Status : Recruiting
First Posted : February 3, 2021
Last Update Posted : November 16, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, drug levels, drug effects, and immunogenicity of BMS-986326 after infusion or injection in healthy participants. The results of this study will guide the selection of the dose range and frequency for future studies of BMS-986326 in participants with immune-mediated diseases.

Condition or disease Intervention/treatment Phase
Healthy Participants Biological: BMS-986326 Other: Placebo matching BMS-986326 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Administration of BMS-986326 in Healthy Participants
Actual Study Start Date : March 3, 2021
Estimated Primary Completion Date : June 14, 2022
Estimated Study Completion Date : June 15, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Active Treatment (BMS 986326) IV
Intravenous (IV)
 Biological: BMS-986326
Specified dose on specified days
Experimental: Active Treatment (BMS 986326) SC
Subcutaneous (SC)
 Biological: BMS-986326
Specified dose on specified days
Placebo Comparator: Placebo IV Other: Placebo matching BMS-986326
Specified dose on specified days
Placebo Comparator: Placebo SC Other: Placebo matching BMS-986326
Specified dose on specified days


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: Up to 57 days ]
  2. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 85 days ]
  3. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 85 days ]
  4. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Up to 85 days ]
  5. Incidence of clinically significant changes in clinical laboratory results: Coagulation tests [ Time Frame: Up to 85 days ]
  6. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Up to 85 days ]
  7. Incidence of clinically significant changes in vital signs: Body temperature [ Time Frame: Up to 85 days ]
  8. Incidence of clinically significant changes in vital signs: Respiratory rate [ Time Frame: Up to 85 days ]
  9. Incidence of clinically significant changes in vital signs: Blood pressure [ Time Frame: Up to 85 days ]
  10. Incidence of clinically significant changes in vital signs: Heart rate [ Time Frame: Up to 85 days ]
  11. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval [ Time Frame: Up to 85 days ]
    PR interval: The time from the onset of the P wave to the start of the QRS complex

  12. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval [ Time Frame: Up to 85 days ]
    QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization

  13. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval [ Time Frame: Up to 85 days ]
    QT interval: Measured from the beginning of the QRS complex to the end of the T wave

  14. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval [ Time Frame: Up to 85 days ]
    QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)

  15. Incidence of clinically significant changes in physical examination findings [ Time Frame: Up to 85 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • In good health, as determined by the investigator based on a physical examination at screening
  • Body mass index (BMI) ≥ 18 and ≤ 30 kg/m^2 at screening
  • Afebrile, with supine systolic blood pressure (BP) ≥ 90 and ≤ 140 mmHg and supine diastolic BP ≥ 50 and ≤ 90 mmHg and heart rate ≥ 50 and ≤ 90 bpm at screening
  • Male participants and women not of child-bearing potential (WNOCBP) are eligible to participate in all cohorts (A1-B3). Women of child-bearing potential (WOCBP) are only eligible for the subcutaneous (SC) cohorts (B1-B3)
  • Must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

  • Women who are pregnant or lactating
  • History of, or active, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, echocardiogram (ECG), or clinical laboratory determinations beyond what is consistent with healthy participants
  • History of serious adverse reaction or hypersensitivity to any (subcutaneous) SC- or (intravenous) IV-administered biological therapeutic, including IV immunoglobulins and human blood products

Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04736134


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
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Germany
Local Institution Recruiting
Berlin, Germany, 10117
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04736134    
Other Study ID Numbers: IM034-001
2020-002763-64 ( EudraCT Number )
U1111-1252-7566 ( Registry Identifier: WHO )
First Posted: February 3, 2021    Key Record Dates
Last Update Posted: November 16, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
BMS-986326
Healthy participants