EUCTR2022-001631-82-BG进行中（未招募）1 期
A Phase 1/2, randomised, placebo-controlled study of EDP2939 in healthy volunteers and participants with moderate plaque psoriasis.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 146
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
- 性别
- All
入选标准
- •All Participants in Parts A and B
- •1. Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. Informed consent will be obtained prior to any screening procedures and in accordance with national, local, and institutional guidelines.
- •2. Contraception:
- •A male participant with a female partner of child-bearing potential must meet the criteria for acceptable contraception as detailed in the protocol during the study and for a period of 90 days after the last dose. All male participants must refrain from donating sperm during this period. 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, as defined in the protocol.
- •II. A woman of child-bearing potential who agrees to follow the contraceptive guidance in the protocol during participation in this study, 28 days prior to the first dose and for at least 1 complete menstrual cycle (=30 days) after the last dose
- •All Participants in Part A Only
- •3. Male or female, aged 18 to 65 years, inclusive, at the time of signing the ICF.
- •4. Body mass index of 18 to 30 kg/m2 inclusive.
- •5. Participant has clinical laboratory evaluations (including haematology, clinical chemistry and urinalysis) within the reference range for the testing laboratory, unless the results are deemed not to be clinically significant by the investigator (1 retest is permitted).
- •6. Overtly healthy as determined by medical evaluation including medical history, physical examination, safety laboratory tests, vital signs and ECG.
- •All Participants in Part B Only
- •7. Males or females aged 18 to 75 years, inclusive, at the time of signing the ICF.
- •8. Body mass index of 18 to 35 kg/m2 inclusive.
- •9. A documented diagnosis of plaque psoriasis, with a patient- or clinician-reported disease duration of at least 6 months prior to screening.
- •10. Have plaque psoriasis meeting all of the following criteria at screening and baseline:
- •a. PGA score of 3 (moderate), and
- •b. BSA =5% and =20%, and
- •c. PASI =5 and =20.
- •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 135
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
排除标准
- •1. Participant has GI tract disease that could interfere with the GI delivery and transit time of EDP2939.
- •2. Participant has an active infection or has had an infection requiring antibiotic treatment within 6 weeks prior to study intervention administration.
- •3. Infection with HIV, HBV, or HCV; or known to be positive for HCV RNA or HbsAg.
- •4. Participant has undergone major surgery within 3 months prior to screening or in whom major surgery is planned during study participation.
- •5. History of neoplastic disease within 5 years of screening except for basal or squamous cell
- •carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.
- •6. History of hypersensitivity or allergies to Prevotella or Prevotella-containing probiotics or any excipients in the IMP, or has a history of hypersensitivity or allergies to capsule shells.
- •7. Participant has received live or live-attenuated vaccination within 6 weeks prior to screening or intends to have such a vaccination during the study. Non-live and non-replicating vaccines are permitted if administered at least 14 days before randomisation.
- •8. Participant has received any investigational drug or experimental procedure within 90 days prior to randomisation.
- •9. Previous participation in a clinical study of EDP1815.
- •10. History of drug abuse or current regular use of illicit drugs or a history of alcohol abuse within 1 year prior to screening.
- •11. Female participant who is pregnant, or plans to become pregnant during the study, or breastfeeding.
- •12. Male participant who intends to donate sperm during the course of this study and for a period of 90 days after the last dose.
- •13. Any other conditions, which, in the opinion of the investigator or sponsor, would make the participant unsuitable for inclusion.
- •14. Any known cardiac abnormality, impairment of cardiac function, or cardiac diseases.
- •15. Any psychiatric or medical conditions that, in the opinion of the investigator, could interfere with treatment, compliance, or the ability to give consent. Participants with a history of any serious psychiatric condition, or on therapy for any psychiatric condition, will be excluded.
- •16. Any prescription medication, vaccination or OTC medication within 14 days prior to randomisation up to the follow up visit, apart from the following:
- •- paracetamol (maximum of 4 grams/day in any 24-hour period)
- •-hormonal contraceptives
- •17. The participant has donated more than 400 mL of blood or blood products within 90 days prior to baseline (Day -1) or plans to donate blood during the study.
- •18. Plaque psoriasis limited to the scalp/ hands / feet.
- •19. Psoriasis flare within 8 weeks prior to screening.
- •20. Evidence of dermatologic conditions that, would interfere with psoriasis evaluation or the assessment of treatment response.
- •21. Use of systemic immunosuppressive therapy, systemic medications that could affect psoriasis or its symptoms, or phototherapy within 28 days of randomisation.
- •22. Treatment with topical medications that could affect psoriasis within 14 days of randomisation. Such topical medications would include, but are not limited to: corticosteroids, topical vitamin D derivatives, retinoids, tazarotene, pimecrolimus, and tacrolimus. Unmedicated emollients and moisturisers are not excluded and may be used throughout the study (but should be withheld on the day of study visits at which skin assessments of psoriasis are made by the investigator (e.g. PASI).
研究者
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