Phase I trial to assess the safety and tolerability of PVX108 in peanut allergic adults

Aravax Pty Ltd0 个研究点目标入组 66 人开始时间: 2017年5月15日最近更新: 2018年11月19日

适应症

试验速览

暂无简介。

•1.Males or females aged 18 to 65 years inclusive at the time of consent
•2.Documented history of allergic reactivity to peanut regardless of severity
•3.Positive response to peanut in a basophil activation test
•4.Peanut-specific serum immunoglobulin E (IgE) measured by ImmunoCAP (Registered Trademark) >0.35 kUA/L
•5.Positive skin prick test (SPT) to peanut with a wheal diameter at least 3 mm, unless in the opinion of the investigator, it is unsafe to perform a SPT
•6.Spirometry testing lung function within the normal range, Forced Expiratory Volume in 1 second (FEV1) at least 80% of predicted at Screening and Visit 1
•7.Bronchodilator reversibility test with change in FEV1 less than 12% and less than 200 mL
•8.Female subjects must be:
•a.of non child-bearing potential [surgically sterilised or post–menopausal (12 months with no menses without alternative medical cause)] OR
•b.not pregnant, breast feeding or planning to become pregnant AND willing to comply with the medically acceptable contraceptive requirements of the study from Screening to at least 28 days after the last Investigational Medicinal Product (IMP) administration

•1.History of or current clinically-significant gastrointestinal, hepatic, renal, cardiovascular, endocrine, oncological, immunological, neurological, ophthalmological, haematological, respiratory or psychiatric disorder or any other condition, which in the opinion of the investigator or sponsor would jeopardise the safety of the subject or the validity of the study results
•2.Random serum tryptase reading less than 11.4 ng/mL
•3.Severe or unstable asthma
•4.History of respiratory related life threatening events or life threatening anaphylaxis in the last 12 months
•5.Subjects with skin disorders that would hinder skin testing and/or its interpretation (eg severe generalised active atopic dermatitis)
•6.Subjects unable to receive beta-2-agonist or anticholinergics that could hinder treatment of an asthmatic response
•7.Use of beta blockers, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers, systemic (oral or injectable) corticosteroids within 2 months prior to Day 1
•8.Prior participation in any interventional study aimed at desensitising peanut allergy within the last 5 years
•9.Subject who received any specific immunotherapy for allergy during the past 12 months, or plans to receive during the course of the study

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