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Not Yet Recruiting

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Healthy Participants - IM034-001

Actualizada: 26 febrero, 2021   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 1

    Fase

  • Géneros

  • 18-50

    Rango de edad

  • 1

    Ubicación (es)

  • Not Yet Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: Active Treatment (BMS 986326) IV
Biological: BMS-986326
Experimental: Active Treatment (BMS 986326) SC
Biological: BMS-986326
Placebo Comparator: Placebo IV
Other: Placebo matching BMS-986326
Placebo Comparator: Placebo SC
Other: Placebo matching BMS-986326

Criterios clave de elegibilidad

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

Recomendamos encarecidamente que se comunique con BMS para informar los efectos secundarios (eventos adversos)
Los efectos secundarios (eventos adversos) y otros eventos reportables se definen aquí
Informe de efectos secundarios (eventos adversos) o quejas sobre la calidad del producto: información médica

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¿Tiene alguna pregunta? El soporte en vivo está disponible 24/7 -
Llame 855-907-3286 o Envíenos un correo electrónico