NL-OMON48298已完成不适用
A phase 1, double-blind, randomised, placebo-controlled multiple dose study investigating the immunopharmacology of EDP1066 with multiple formulations - MAD immunopharmacology study of EDP1066 with multiple formulations
Evelo Biosciences Inc.0 个研究点目标入组 80 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 Screening.
- •4. Contraception:
- •a. Male participants:
- •* A male participant must agree to use contraception as indicated in Section
- •4.5.1 during their participation in this study and for a period of 90 days
- •after the last dose and refrain from donating sperm during this period.
- •b. Female participants:
- •* A female participant is eligible to participate if she is not pregnant, does
- •not plan to become pregnant during the study, 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 as indicated in Section 4.5.1 and for at least 3
- •complete menstrual cycles (*90 days) after last EDP1066 dose.
- •5. CRP * 10 mg/L and faecal calprotectin * 150 mcg/g faeces. Exceedings of
- •these thresholds may be allowed by the investigator if deemed clinically
- •irrelevant.
- •6. 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. Participant has the ability to communicate well with the Investigator in the
- •Dutch language and willing to comply with the study restrictions.
- •9. Subject needs to have sufficient space in a refrigerator to store the IMP
- •during the ambulant dosing phase.
排除标准
- •1. Participant has received live attenuated vaccination within 42 days prior to
- •Screening or intends to have vaccinations during the course of the study.
- •2. Participant has received any investigational drug or experimental procedure
- •within 90 days or 5 half-lives, whichever is longer, prior to study
- •intervention administration or participant was enrolled in an investigational
- •drug or device study within 90 days prior to first EDP1066 dosing.
- •3. Participant requires treatment with an anti-inflammatory drug or
- •prophylactic antibiotics for any reason 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).
- •4. Participant has an active infection (e.g. sepsis, pneumonia, abscess) or
- •recurrent infection, or has had an infection requiring antibiotic treatment
- •within 42 days prior to Investigational Medicinal Product (IMP) administration.
- •5. 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 56 days of planned drug administration or planning to travel to
- •countries where TB is endemic from the moment of drug administration until 90
- •days after the end of the study.
- •6. Participant has renal or liver impairment, defined as:
- •a. For women, serum creatinine level * 125 *mol/L; for men, * 135 *mol/L
- •b. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) * 1.5 x
- •upper limit of normal (ULN), or
- •c. Alkaline phosphatase (ALP) and/or bilirubin > 1.5 x ULN
- •Exceedings of these thresholds may be allowed by the investigator if deemed
- •clinically irrelevant.
- •7. 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
- •8. Impaired cardiac function or clinically significant cardiac diseases,
- •including any of the following:
- •a. Unstable angina or acute myocardial infarction * 90 days prior to Screening;
- •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.
- •9. Participant with a positive screening result for hepatitis B surface
- •antigen, anti-hepatitis B core, hepatitis C, or HIV.
- •10. 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.
- •11. Serious psychiatric or medical conditions that, in the opinion of the
- •investigator, could interfere with treatment, compliance, or the ability to
- •give consent.
- •12. Participant has a history of hypersensitivity or allergies to Lactococcus
- •(or Lactococcus containing probiotics) including any associated excipients, or
- •has a history of hypersensitivity or allergies to placebo capsule/powder
- •(magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide,
- •hydroxypropylmethylcellulose, o
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