3 results match your criteria: "Janssen Clinical Pharmacology Unit[Affiliation]"
Data driven evaluation of healthy volunteer characteristics at screening for phase I clinical trials to inform on study design and optimize screening processes.
Clin Transl Sci
November 2021
Janssen Clinical Pharmacology Unit, Merksem, Belgium.
Article Synopsis
- Clinical trial protocols set inclusion and exclusion criteria to protect participant safety and ensure data quality, especially during phase I trials with healthy volunteers (HVs).
- A study analyzing data from 3365 HVs revealed that predicted screen failure rates (SFRs) were high in relation to cardiovascular, metabolic, renal, liver, and coagulation parameters, particularly as age increased.
- This analysis highlights the importance of refining screening processes and inclusion/exclusion criteria to minimize screen failures, ultimately leading to more efficient clinical trial execution while maintaining participant safety.
Interim Results of a Phase 1-2a Trial of Ad26.COV2.S Covid-19 Vaccine.
N Engl J Med
May 2021
From Janssen Vaccines and Prevention, Leiden, the Netherlands (J. Sadoff, M.L.G., G. Shukarev, A.M.G., J. Stoop, S.T., E.C., G. Scheper, J. Hendriks, M.D., J.V.H., H.S.); Janssen Research and Development, Beerse (D.H., C.T., F.S.), Janssen Clinical Pharmacology Unit, Merksem (W.V.D.), the Center for Vaccinology, Ghent University, Gent (I.L.-R.), SGS Life Sciences (P.-J.B.) and the Center for the Evaluation of Vaccination, University of Antwerp (P.V.D.), Antwerp, and the Center for Clinical Pharmacology, University Hospitals Leuven, Leuven (J. de Hoon) - all in Belgium; Optimal Research, Melbourne, FL (M.K.); the Alliance for Multispecialty Research, Knoxville, TN (W.S.); the Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston (K.E.S., D.H.B.); and the Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle (S.C.D.R., K.W.C., M.J.M.).
Background: Efficacious vaccines are urgently needed to contain the ongoing coronavirus disease 2019 (Covid-19) pandemic of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). A candidate vaccine, Ad26.COV2.
View Article and Find Full Text PDFSafety, tolerability and pharmacokinetics of rilpivirine following administration of a long-acting formulation in healthy volunteers.
HIV Med
September 2015
Janssen Infectious Diseases BVBA, Beerse, Belgium.
Objectives: This phase I healthy volunteer study (NCT01031589) was carried out to investigate the safety/tolerability and pharmacokinetics of a rilpivirine (RPV; TMC278) long-acting (LA) formulation after single and multiple intramuscular (i.m.) injections.
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