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)

Completed

Conditions: Cow's milk allergy and rabbit allergy
10001708

Registration Number: NL-OMON39068

Lead Sponsor: Pharming Technologies B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Reactivity by both skin test procedures and severity of adverse events (AEs)<br /><br>following subcutaneous challenge.<br /><br>Number of subjects who experienced a positive skin reaction, as measured by a >=<br /><br>3-mm wheal over the negative control (SPT) and/or an erythema that equals or<br /><br>exceeds in mean diameter the positive control (ICT).<br /><br>Endpoint will be evaluated by recording local reactions and systemic symptoms<br /><br>of type I hypersensitivity. The negative predictive value of the skin test<br /><br>protocol will be assessed as the number of subjects without systemic reaction<br /><br>upon subcutaneous challenge over the number of subjects having tested negative<br /><br>for the SPT and ICT.</p><br>

Secondary Outcome Measures