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OpenTrials
Completed

NCT Number: NCT04736134

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

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, dosing frequency, and the route of administration for future studies of BMS-986326 in participants with immune-mediated diseases.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 are eligible to participate in cohorts (A1-B3).Women not of child bearing potential (WNOCBP) are eligible to participate in all cohorts (A1-B3 and C1-C2) Women of child-bearing potential (WOCBP) are only eligible for the subcutaneous (SC) cohorts (B1-B3 and C1-C2)
  • 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

Treatment and study plan

BMS-986326

Biological

Specified dose on specified days

Placebo matching BMS-986326

Other

Specified dose on specified days

Multiple Ascending Dose SC

Biological

Specified dose on specified days

Multiple Ascending Dose Placebo

Other

Specified dose on specified days

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 175 days

  2. Number of participants with clinical laboratory abnormalities

    Time frame: Up to 175 days

  3. Number of participants with vital sign abnormalities

    Time frame: Up to 175 days

  4. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to 175 days

  5. Number of participants with physical examinations abnormalities

    Time frame: Up to 175 days

Secondary outcomes

  1. Maximum observed serum concentration (Cmax)

    Time frame: Up to 175 days

  2. Time of maximum observed serum concentration (Tmax)

    Time frame: Up to 175 days

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

    Time frame: Up to 175 days

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

    Time frame: Up to 175 days

  5. Change in regulatory T cells (Treg) count

    Time frame: Up to 175 days

  6. Change in Treg-to-conventional CD4 cells [Treg-to-Tconv] ratio

    Time frame: Up to 175 days

  7. Number of participants with anti-drug antibodies

    Time frame: Up to 175 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Double-blind, Placebo-controlled, Randomized, Single and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Administration of BMS-986326 in Healthy Participants

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 3, 2021
Registry last updated
May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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