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Active, Not Recruiting

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

Mis à jour: 6 février, 2024   |   ClinicalTrials.gov

Communiquez avec nous pour obtenir de l’aide
833-673-6134

Impression du resumé

SONGEZ-VOUS À PARTICIPER À CET ESSAI?
Imprimez cette page et le guide pour vous aider dans vos échanges avec votre médecin.
Utilisez le guide en matière d’essai pour connaître le processus de participation à un essai clinique. Soyez au fait des principaux facteurs à considérer avant de prendre une décision et dressez la liste des questions à poser à l’équipe de soins de santé.

Détails de l’essai

  • Phase 1

    Phase

  • Sexe(s)

  • 18-50

    Tranche d’âge

  • Active, Not Recruiting

Options de traitement

Groupes de l’étude
INTERVENTION ATTRIBUÉE
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

Principaux critères d’admissibilité

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

Nous vous recommandons fortement de contacter BMS pour signaler les effets secondaires (événements indésirables).
Les effets secondaires (événements indésirables) et les autres événements à signaler sont définis ici.
Signaler des effets secondaires (effets indésirables) ou des plaintes concernant la qualité du produit: Informations médicales

Des questions? Le support en direct est disponible 24/7 - Veuillez composer le 833-673-6134 ou Envoyez-nous un courriel

Des questions? Le support en direct est disponible 24/7 -
Veuillez composer le 833-673-6134 ou Envoyez-nous un courriel