A Phase I study to assess in vitro and in vivo immunoreactivity of Ruconest in Subjects with cow's milk allergy (CMA) and/or rabbit allergy (RA) - Ruconest skin prick test validation protocol

Pharming Technologies B.V.0 个研究点目标入组 25 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•Positive SPT and/or IgE >0.35 for CM and/or positive SPT and/or IgE >0.35 for rabbit dander
•Signed written informed consent
•Males and females between 18 and 65 years old
•Medical records documenting clinical CMA and/or RA or suggestive history of symptoms
•Physical examination findings within normal limits
•Willingness and ability to comply with all protocol procedures

•Pregnancy or breastfeeding, or current intention to become pregnant
•Severe dermographism
•Other concurrent disease or condition that would interfere, or for which the treatment might interfere with the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to individuals in this study
•Treatment with drugs that interfere with skin test response
•History or symptoms of significant psychiatric disease, including depression and schizophrenia
•Known or suspected addiction to drug and/or alcohol abuse
•Participation in an investigational drug or device trial within the last 30 days prior to screening

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