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Cerca in Study Connect

Not Yet Recruiting

A Study to Evaluate the Drug Levels of Abatacept Converted From Drug Substance by Two Different Processes in Healthy Participants - IM101-920

Aggiornato: 1 agosto, 2023   |   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

  • 18-55

    Fascia d'età

  • 3

    Sede/i

  • Not Yet Recruiting

Opzioni di trattamento

Bracci dello studio
INTERVENTO ASSEGNATO
Experimental: Abatacept Treatment A
Biological: Abatacept
Experimental: Abatacept Treatment B
Biological: Abatacept

Principali criteri di idoneità

Inclusion Criteria: - Healthy participants, defined as having no clinically significant deviation from normal in medical history; physical examinations that would compromise the ability to participate, complete, and/or interpret the results of the study; 12-lead ECG; vital signs; and clinical laboratory results - Body weight between 60 and 100 kilograms (kg) inclusive, based on weight at screening - Participant must have a suitable injection site without tattoos, scarring, or other conditions in the upper, outer arm that could interfere with SC administration Exclusion Criteria: - Present malignancy or previous malignancy within the last 5 years prior to screening - At risk for tuberculosis - Any chronic bacterial infection within the previous 12 weeks of dosing 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