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Ícono de BMS, estudio Activo, no reclutando

Active, Not Recruiting

ID del estudio IM034-001  |   NCT04736134

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

Ícono de advertencia
Lo sentimos, este estudio ya no acepta nuevos participantes, pero aún está en curso.
Puede hacer clic en el botón “Verificar su Elegibilidad” y responder algunas preguntas sobre su salud para averiguar si podría ser compatible con otro estudio.
Comuníquese con nosotros si necesita ayuda
855-907-3286

Resumen

  • Phase 1
  • Ícono de género masculino y femenino
  • 18-50
  • Ícono de BMS, estudio Activo, no reclutando
    Active, Not Recruiting

Descripción general

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.

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

Opciones de tratamiento

Brazos del estudio

INTERVENCIÓN ASIGNADA

Brazos del estudio

Experimental: Active Treatment (BMS 986326) IV

INTERVENCIÓN ASIGNADA
  • Biological: BMS-986326

Brazos del estudio

Experimental: Active Treatment (BMS 986326) SC

INTERVENCIÓN ASIGNADA
  • Biological: BMS-986326

Brazos del estudio

Placebo Comparator: Multiple Ascending Dose Placebo SC

INTERVENCIÓN ASIGNADA
  • Other: Multiple Ascending Dose Placebo

Brazos del estudio

Experimental: Multiple Ascending Dose SC

INTERVENCIÓN ASIGNADA
  • Biological: Multiple Ascending Dose SC

Brazos del estudio

Placebo Comparator: Placebo IV

INTERVENCIÓN ASIGNADA
  • Other: Placebo matching BMS-986326

Brazos del estudio

Placebo Comparator: Placebo SC

INTERVENCIÓN ASIGNADA
  • Other: Placebo matching BMS-986326

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

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