NL-OMON20845尚未招募不适用
A phase 1a, double blind, placebo-controlled, randomised multipleascending dose study evaluating the effects of EDP1815 in the KLH antigenchallenge in healthy volunteers
Evelo Biosciences Inc.0 个研究点目标入组 48 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
研究概览
简要总结
.A.
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Participants are eligible to be included in the study only if all of the
- •following criteria apply:
- •1. Capable of giving signed informed consent which includes compliance
- •with the requirements and restrictions listed in the informed consent form
- •(ICF) and in this protocol. Obtained prior to any screening procedures and
- •in accordance with national, local, institutional guidelines.
- •2. Age = 18 years to 60 years, inclusive.
- •3. Participant has a body mass index of = 18 kg/m2 to = 35 kg/m2 at
- •4. Contraception:
- •a. Male participants:
- •A male participant must agree to use contraception during their
- •participation in this study and for a period of 90
- •days after the last dose and refrain from donating sperm during this
- •b. Female participants:
- •A female participant is eligible to participate if she is not pregnant, not
- •breastfeeding, and at least 1 of the
- •following conditions applies:
- •i. Not a woman of child-bearing potential (WOCBP)
- •ii. A WOCBP who agrees to follow the contraceptive guidance during their
- •participation in this study and for at least 1 complete menstrual cycle (=30
- •days) after last dose.
- •5. CRP = 10 mg/L and faecal calprotectin = 150 mcg/g faeces
- •6. The participant has clinical laboratory evaluations (including clinical
- •chemistry, haematology, and complete urinalysis) within the reference
- •range for the testing laboratory, unless the results are deemed not to be
- •clinically significant by the investigator (1 repeat test is permitted).
- •7. Participants who are overtly healthy as determined by medical
- •evaluation including medical history, physical examination, laboratory
- •tests, and cardiac monitoring at Screening and on Day 1.
- •8. Subject needs to have sufficient space in a refrigerator to store the IMP
- •during the ambulant dosing phase.
- •9. Participant has the ability to communicate well with the Investigator in
- •the Dutch language and willing to comply with the study restrictions.
排除标准
- •1. Female participant who is pregnant, or plans to become pregnant
- •during the study, or breastfeeding, or sexually active with child-bearing
- •potential who is not using a medically accepted birth control method.
- •2. Participant has received live attenuated vaccination within 6 weeks
- •prior to Screening or intends to have vaccinations during the course of the
- •3. Participant has received any investigational drug or experimental
- •procedure within 90 days or 5 half-lives, whichever is longer, prior to study
- •intervention administration.
- •4. Participant was enrolled in an investigational drug or device study
- •within 3 months prior to first dosing.
- •5. Participant requires treatment with an anti-inflammatory drug during
- •the study period. Paracetamol will be permitted for use as an antipyretic
- •and/or analgesic (maximum of 4 grams/day in any 24-hour period).
- •6. Participant has an active infection (e.g. sepsis, pneumonia, abscess) or
- •recurrent infection, or has had an infection requiring antibiotic treatment
- •within 6 weeks prior to Investigational Medicinal Product (IMP)
- •administration.
- •7. Participant is diagnosed with tuberculosis (TB, as per positive skin test
- •(Mantoux) or IFN-? release assay), or history of TB, or latent TB, or recent
- •contact with TB (patient); having travelled to countries where TB is
- •endemic within eight weeks of planned drug administration or planning to
- •travel to countries where TB is endemic from the
- •moment of drug administration until three months after the end of the
- •8. Patient requires prophylactic antibiotics for any reason
- •9. Participant has renal or liver impairment, defined as:
- •a. For women, serum creatinine level = 125 µmol/L; for men, = 135 µmol/L
- •b. An estimated creatinine clearance (MDRD formula) <60 mL/min
- •c. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =
- •1.5 x upper limit of normal (ULN), or
- •d. Alkaline phosphatase (ALP) and/or bilirubin > 2.5 x ULN
- •10. Participant has active neoplastic disease or history of neoplastic
- •disease within 5 years of Screening (except for basal or squamous cell
- •carcinoma of the skin or carcinoma in situ that has been definitively
- •treated with standard of care).
- •11. Impaired cardiac function or clinically significant cardiac diseases,
- •including any of the following:
- •a. Unstable angina or acute myocardial infarction = 3 months prior to
- •b. Clinically significant heart disease (e.g. symptomatic congestive heart
- •failure [e.g. >New York Heart Association
- •[NYHA] Class 2]; uncontrolled arrhythmia, or hypertension; history of
- •labile hypertension or poor compliance with an antihypertensive regimen.
- •12. Participant with a positive screening result for hepatitis B surface
- •antigen, anti-hepatitis B core, hepatitis C, or HIV.
- •13. Participants with gastrointestinal tract disease (e.g. short bowel
- •syndrome, diarrhoea predominant irritable bowel syndrome [IBS], celiac
- •disease) that could interfere with the subject’s safety or
- •pharmacodynamic effect of the monoclonal microbial.
- •14. Serious psychiatric or medical conditions that, in the opinion of the
- •investigator, could interfere with treatment, compliance, or the ability to
- •give consent.
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