NCT04736134

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2021

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
28 days until next milestone

Study Start

First participant enrolled

March 3, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2024

Completed
Last Updated

May 6, 2024

Status Verified

April 1, 2024

Enrollment Period

3 years

First QC Date

January 29, 2021

Last Update Submit

May 3, 2024

Conditions

Healthy Participants

Keywords

BMS-986326Healthy participants

Outcome Measures

Primary Outcomes (5)

  • Number of participants with adverse events (AEs)

    Up to 175 days

  • Number of participants with clinical laboratory abnormalities

    Up to 175 days

  • Number of participants with vital sign abnormalities

    Up to 175 days

  • Number of participants with electrocardiogram (ECG) abnormalities

    Up to 175 days

  • Number of participants with physical examinations abnormalities

    Up to 175 days

Secondary Outcomes (7)

  • Maximum observed serum concentration (Cmax)

    Up to 175 days

  • Time of maximum observed serum concentration (Tmax)

    Up to 175 days

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

    Up to 175 days

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

    Up to 175 days

  • Change in regulatory T cells (Treg) count

    Up to 175 days

  • +2 more secondary outcomes

Study Arms (6)

Active Treatment (BMS 986326) IV

EXPERIMENTAL

Intravenous (IV)

Biological: BMS-986326

Active Treatment (BMS 986326) SC

EXPERIMENTAL

Subcutaneous (SC)

Biological: BMS-986326

Placebo IV

PLACEBO COMPARATOR
Other: Placebo matching BMS-986326

Placebo SC

PLACEBO COMPARATOR
Other: Placebo matching BMS-986326

Multiple Ascending Dose Placebo SC

PLACEBO COMPARATOR

Placebo

Other: Multiple Ascending Dose Placebo

Multiple Ascending Dose SC

EXPERIMENTAL

BMS 986326 SC

Biological: Multiple Ascending Dose SC

Interventions

BMS-986326BIOLOGICAL

Specified dose on specified days

Active Treatment (BMS 986326) IVActive Treatment (BMS 986326) SC
Placebo matching BMS-986326OTHER

Specified dose on specified days

Placebo IVPlacebo SC
Multiple Ascending Dose SCBIOLOGICAL

Specified dose on specified days

Multiple Ascending Dose SC
Multiple Ascending Dose PlaceboOTHER

Specified dose on specified days

Multiple Ascending Dose Placebo SC

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution - 0001

Berlin, 10117, Germany

Location

Related Links

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 3, 2021

Study Start

March 3, 2021

Primary Completion

March 14, 2024

Study Completion

March 14, 2024

Last Updated

May 6, 2024

Record last verified: 2024-04

Locations

DE(1)