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Ícono de BMS, studio Reclutando

Recruiting

ID del estudio CN008-0028  |   NCT07780383

A Study to Evaluate the Drug Levels, Absolute Bioavailability, Safety, Tolerability, and Immunogenicity of Single-Dose of BMS-986446 in Healthy Adults After Single-dose Administration, and Participants With Early Alzheimer's Disease After Multiple Dose Administration

Resumen

  • Phase 1
  • Ícono de género masculino y femenino
  • 18-80
  • 1
  • Ícono de BMS, studio Reclutando
    Recruiting

Descripción general

The purpose of this study is to evaluate the drug levels, absolute bioavailability, safety, tolerability, and immunogenicity of single-Dose of BMS-986446 in healthy adults after single-dose administration, and participants with early Alzheimer's Disease after multiple dose administration

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Criterios clave de elegibilidad

Criterios de inclusión

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  • Participants must have a BMI of 18.0 to 35.0 kg/m2.
    1. For Parts A and B: Participants must be healthy as determined by medical history, Physical Examination (PE), neurological examination, vital signs, 12-lead ECG, Columbia Suicide-Severity Rating Scale (C-SSRS), and clinical laboratory evaluations.
      1. For Part C: Participants must meet diagnostic criteria for MCI or mild AD dementia, consistent with the National Institute on Aging and the Alzheimer's Association (NIA-AA) diagnostic criteria.
        1. For Part C: Participants must have an Mini Mental State Examination (MMSE) score of ≥ 20 to 28 (inclusive).
          1. For Part C: Participants must have evidence of positive plasma pTau217.

            Criterios de exclusión

            Criterios de exclusión Icon
            • For Parts A and B: Participants must not have a general history of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, immune-mediated disorder, hematological, ongoing allergic disorder requiring treatment, metabolic disorder, cancer, or cirrhosis.
              1. For Parts A and B: Participants must not have donated or lost 500 mL blood or more within 60 days prior to study intervention administration.
                1. For Part C: Participants must not have a neurological condition that in the opinion of the investigator may be contributing to cognitive impairment aside from the AD diagnosis, including but not limited to: Parkinson's disease, vascular dementia, dementia with Lewy bodies, frontotemporal dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, long COVID, or baseline intellectual disability.
                  1. For Part C: Participants must not have any current primary psychiatric diagnosis (eg, major depression, schizoaffective disorder or bipolar disorder) other than AD or symptoms (eg, hallucination or delusions).
                    Información Adicional *
                    • Other protocol-defined Inclusion/Exclusion criteria apply.

                      Opciones de tratamiento

                      Brazos del estudio

                      INTERVENCIÓN ASIGNADA

                      Brazos del estudio

                      Experimental: Panel A1: BMS986446

                      INTERVENCIÓN ASIGNADA
                      • Drug: BMS-986446

                      Brazos del estudio

                      Experimental: Panel A2: BMS986446

                      INTERVENCIÓN ASIGNADA
                      • Drug: BMS-986446

                      Brazos del estudio

                      Experimental: Panel A3: BMS986446

                      INTERVENCIÓN ASIGNADA
                      • Drug: BMS-986446

                      Brazos del estudio

                      Experimental: Panel B1: BMS986446

                      INTERVENCIÓN ASIGNADA
                      • Drug: BMS-986446

                      Brazos del estudio

                      Experimental: Panel B2: BMS986446

                      INTERVENCIÓN ASIGNADA
                      • Drug: BMS-986446

                      Brazos del estudio

                      Experimental: Panel C1: BMS986446

                      INTERVENCIÓN ASIGNADA
                      • Drug: BMS-986446
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