EUCTR2018-000165-36-DK进行中（未招募）1 期
A Phase 1b, Open-Label, Multiple-Dose, Proof-of-Concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AK002 in Patients with Peanut Allergy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Able to provide written informed consent
- •2) Male or female aged =18 and =80 years at the time of signing the ICF
- •3) Clinical history of allergy to peanuts or peanut-containing foods, with serum IgE antibodies to Ara h2 of =2 kUA/L (determined by the UniCAP™ automated immunoassay system) and peanut skin prick test wheal diameter =3 mm larger compared with control (calculated per Section 10.5.3))
- •4) Experiences dose-limiting allergic symptoms at or before reaching the 300 mg single dose of peanut protein (443 mg cumulative) during the baseline food challenge (Food Challenge 1)
- •5) Willing and able to comply with the study procedures and visit schedule
- •6) Female patients must be either post-menopausal for at least 1 year at Screening or surgically sterile (tubal ligation, hysterectomy or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use dual methods of contraception, or abstain from sexual activity from Screening until the end of the study, or for 120 days following the last dose of study drug, whichever is longer.
- •Male patients with female partners of childbearing potential must agree to use a highly effective method of contraception from Screening until the end of the study or for 120 days following the last dose of study drug, whichever is longer. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant (e.g., missed or late menstrual period) at any time during study participation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1) Known hypersensitivity to any constituent of the study
- •2) Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study
- •3) Presence of abnormal laboratory values considered to be clinically significant by the Investigator
- •4) Any disease or condition (medical or surgical) which, in the opinion of the Investigator, would place the patient at increased risk
- •5) History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension
- •6) History of malignancy, except carcinoma in situ in the cervix, early stage prostate cancer or non-melanoma skin cancers
- •7) Participation in a concurrent interventional study with the last intervention occurring within 30 days prior to administration of study drug (or 90 days or 5 half-lives, whichever is longer, for biologic products)
- •8) Treatment with chemotherapy or radiotherapy in the preceding 6 months
- •9) Treatment for a clinically significant helminthic parasitic infection within 6 months of screening
- •10) Use during the 30 days before Screening (or 5 half-lives, whichever is longer) or use during the Screening Period of systemic corticosteroids
- •11) Vaccination with live attenuated vaccines within 30 days prior to initiation of treatment, during the Treatment Period, or vaccination expected within 5 half-lives (4 months) of study drug administration
- •12) Known history of alcohol, drug, or other substance abuse or dependence
- •13) Any other reason that (in the opinion of the Investigator or Medical Monitor) makes the patient unsuitable for enrollment
研究者
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