NL-OMON51644已完成不适用
A phase 1, randomized, double-blind, placebo-controlled, multiple dose platform study investigating the immunopharmacology of EDP1815 and EDP2939 - Evaluation of the Immunopharmacology of EDP1815 and EDP2939
Evelo Biosciences0 个研究点目标入组 72 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
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 64（—）
入选标准
- •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 45 years, inclusive.
- •3. Participant has a body mass index of >= 18 kg/m2 to <= 35 kg/m2 at Screening.
- •6. The participant has clinical laboratory evaluations (including clinical
- •chemistry, haematology, and complete urine analysis) 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. Fitzpatrick skin type I-III (Caucasian).
- •8. Participants who are overtly healthy as determined by medical evaluation
- •including medical history, vital signs, physical examination, laboratory tests
- •and ECGs at Screening and on Day -1.
排除标准
- •9. The participant has used Aldara® (imiquimod cream) within 3 weeks prior to
- •the baseline visit or plans to use it during the course of the study.
- •10. Previous known exposure to Immucothel® or KLH.
- •12. The participant has a history of hypersensitivity or allergies to
- •Prevotella (or Prevotella containing probiotics) including any associated
- •excipients for EDP1815 or EDP2939, or has a history of hypersensitivity or
- •allergies to placebo capsule/powder (magnesium stearate, microcrystalline
- •cellulose, colloidal silicon dioxide, hydroxypropylmethylcellulose, or
- •mannitol) or to the hard capsule shells (hydroxylpropylmethylcellulose and
- •titanium dioxide), or has a known allergy against Alhydrogel®, or has a known
- •allergy against Aldara® (imiquimod cream).
- •16. The participant has any current and / or recurrent pathologically,
- •clinically significant skin condition at the treatment area (i.e., atopic
- •dermatitis), including tattoos. Treatment area includes the forearms and back.
- •19. History of pathological scar formation (keloid, hypertrophic scar) or
- •keloids or surgical scars in the target treatment area that in the opinion of
- •the investigator, would limit or interfere with dosing and/or measurement in
- •20. Diagnosed with psoriasis.
- •21. History of skin cancer (basal cell carcinoma, squamous cell carcinoma,
- •22. Tanning due to sunbathing, excessive sun exposure or a tanning booth within
- •3 weeks before start of treatment (Day 1) and for the duration of the study.
- •23. History of Schistosomiasis (infection with Schistosoma parasite).
研究者
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