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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Other: Multiple Ascending Dose Placebo; Biological: BMS-986326; Other: Placebo matching BMS-986326; Biological: Multiple Ascending Dose SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT04736134

IM034-001

2020-002763-64 (EudraCT Number)

U1111-1252-7566 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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88 participants in 6 patient groups, including a placebo group

Active Treatment (BMS 986326) IV

Experimental group

Description:

Intravenous (IV)

Treatment:

Biological: BMS-986326

Active Treatment (BMS 986326) SC

Experimental group

Description:

Subcutaneous (SC)

Treatment:

Biological: BMS-986326

Placebo IV

Placebo Comparator group

Treatment:

Other: Placebo matching BMS-986326

Placebo SC

Placebo Comparator group

Treatment:

Other: Placebo matching BMS-986326

Multiple Ascending Dose Placebo SC

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Multiple Ascending Dose Placebo

Multiple Ascending Dose SC

Experimental group

Description:

BMS 986326 SC

Treatment:

Biological: Multiple Ascending Dose SC