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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04736134
Collaborator
(none)
72
1
4
16.6
4.3

Study Details

Study Description

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
  • Biological: BMS-986326
  • Other: Placebo matching BMS-986326
Phase 1

Study Design

Study Type:
Interventional
Anticipated 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 :
Mar 3, 2021
Anticipated Primary Completion Date :
Jul 20, 2022
Anticipated Study Completion Date :
Jul 20, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. Number of participants with adverse events (AEs) [Up to 119 days]

  2. Number of participants with clinical laboratory abnormalities [Up to 119 days]

  3. Number of participants with vital sign abnormalities [Up to 119 days]

  4. Number of participants with electrocardiogram (ECG) abnormalities [Up to 119 days]

  5. Number of participants with physical examinations abnormalities [Up to 119 days]

Secondary Outcome Measures

  1. Maximum observed serum concentration (Cmax) [Up to 119 days]

  2. Time of maximum observed serum concentration (Tmax) [Up to 119 days]

  3. Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] [Up to 119 days]

  4. Geometric mean ratios of test (SC) vs reference (IV): Cmax [Up to 119 days]

  5. Geometric mean ratios of test (SC) vs reference (IV): AUC(0-T) [Up to 119 days]

  6. Geometric mean ratios of test (SC) vs reference (IV): Area under the serum concentration-time curve extrapolated to infinite time [AUC(INF)] [Up to 119 days]

  7. Change in regulatory T cells (Treg) count [Up to 119 days]

  8. Change in Treg-to-conventional CD4 cells [Treg-to-Tconv] ratio [Up to 119 days]

  9. Number of participants with anti-drug antibodies [Up to 119 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Local Institution - 0001 Berlin Germany 10117

Sponsors and Collaborators

  • Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT04736134
Other Study ID Numbers:
  • IM034-001
  • 2020-002763-64
  • U1111-1252-7566
First Posted:
Feb 3, 2021
Last Update Posted:
Apr 20, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bristol-Myers Squibb

Study Results

No Results Posted as of Apr 20, 2022