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Cerca in Study Connect

Active, Not Recruiting

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

Aggiornato: 6 febbraio, 2024   |   ClinicalTrials.gov.

Stampi il riassunto semplice

STA PRENDENDO IN CONSIDERAZIONE QUESTA SPERIMENTAZIONE?
Stampi questa pagina e la guida alla sperimentazione da utilizzare come supporto nel colloquio con il Suo medico.
Utilizzi la Guida per i partecipanti allo studio per esplorare il processo di partecipazione a una sperimentazione clinica. Comprenda i fattori chiave da considerare prima di decidere e pensi alle domande da porre al Suo team di professionisti sanitari.

Dettagli della sperimentazione

  • Phase 1

    Fase

  • Sesso

  • 18-50

    Fascia d'età

  • Active, Not Recruiting

Opzioni di trattamento

Bracci dello studio
INTERVENTO ASSEGNATO
Experimental: Active Treatment (BMS 986326) IV
Biological: BMS-986326
Experimental: Active Treatment (BMS 986326) SC
Biological: BMS-986326
Placebo Comparator: Multiple Ascending Dose Placebo SC
Other: Multiple Ascending Dose Placebo
Experimental: Multiple Ascending Dose SC
Biological: Multiple Ascending Dose SC
Placebo Comparator: Placebo IV
Other: Placebo matching BMS-986326
Placebo Comparator: Placebo SC
Other: Placebo matching BMS-986326

Principali criteri di idoneità

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

Ti consigliamo vivamente di contattare BMS per segnalare gli effetti collaterali (eventi avversi)
Qui vengono definiti gli effetti collaterali (eventi avversi) e altri eventi da segnalare
Segnala effetti collaterali (eventi avversi) o reclami sulla qualità del prodotto: informazioni mediche