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Clinical Trials/NL-OMON48298
NL-OMON48298CompletedNot Applicable

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 sites80 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
80
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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

Investigators

Sponsor
Evelo Biosciences Inc.

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