NL-OMON48156已完成不适用
A Randomized, Double-Blind, Vehicle-Controlled, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Topically Applied INM-755 Cream in Healthy Volunteers - Topical INM-755 in healthy volunteers and blister wound model
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
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
- •1. Male or female subject between 18 and 45 years of age inclusive at the time
- •of consent.
- •2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive
- •3. Subject is in good general health, according to the investigator*s judgment
- •based on vital signs, medical history, physical examination, and laboratory
- •tests performed.
- •4. Contraception:
- •a. Male participants:
- •i. A male participant who agrees to follow the contraceptive guidance during
- •their participation in this study from at least 4 weeks before Day 1 until at
- •least 4 weeks after the last study product administration. Effective
- •contraceptive methods are described in the protocol
- •b. Female participants:
- •i. 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:
- •1. Not a woman of child-bearing potential (WOCBP)
- •2. A WOCBP who agrees to follow the contraceptive guidance during their
- •participation in this study from at least 4 weeks before Day 1 until at least 4
- •weeks after the last study product administration. Effective contraceptive
- •methods are described in Section 4.5.1.
- •5. Female subject has had a negative urine pregnancy test at screening and at
- •Day 1 before dosing.
- •6. Subject is willing to participate and is capable of giving informed consent.
- •7. Subjects must be willing to comply with all study procedures, have the
- •ability to communicate well with the investigator in the Dutch language and
- •must be available for the duration of the study.
- •8. Subject has sufficient application area of healthy intact skin of the back.
排除标准
- •A subject who meets any of the following criteria at screening and at Day 1
- •before dosing, unless specified otherwise, will be excluded from participation
- •in this study:
- •1. Subject is a female who is breastfeeding, pregnant, or who is planning to
- •become pregnant during the study.
- •2. Subject has a history of skin disease or presence of skin condition that, in
- •the opinion of the investigator, would interfere with the study assessments.
- •3. Subject has presence of or has a history of atopic dermatitis or psoriasis.
- •4. Any known allergy or hypersensitivity to medical adhesives (e.g., Tegaderm)
- •used in this study or any component of the study product (e.g. Poloxamers,
- •Lecithin, Isopropyl Palmitate).
- •5. Subject has presence of any tattoos, scratches, open sores, excessive hair,
- •or skin damages in the target treatment area(s) that, in the opinion of the
- •investigator, may interfere with study evaluations.
- •6. Subject has a Fitzpatrick*s Skin Phototype *4.
- •7. Subject is known to have immune deficiency or is immunocompromised.
- •8. Subject has a known history of chronic infectious disease (eg, hepatitis B,
- •hepatitis C, or infection with human immunodeficiency virus).
- •9. Subject has a history of cancer or lymphoproliferative disease within 5
- •years prior to Day 1. Subjects with successfully treated nonmetastatic
- •cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in
- •situ of the cervix are not to be excluded.
- •10. Subject had a major surgery within 8 weeks prior to Day 1 or has a major
- •surgery planned during the study.
- •11. Subject has any clinically significant medical condition or physical,
- •laboratory, ECG, or vital signs abnormality that would, in the opinion of the
- •investigator, put the subject at undue risk or interfere with interpretation of
- •study results.
- •12. Subject has used any systemic treatment that could be immunosuppressive
- •(including oral corticosteroids, oral retinoids, immunosuppressive medication,
- •methotrexate, cyclosporine, or apremilast) within 4 weeks prior to Day 1. Note:
- •Intranasal corticosteroids and inhaled corticosteroids are allowed. Eye and ear
- •drops containing corticosteroids are also allowed.
- •13. Subject has had excessive sun exposure, is planning a trip to a sunny
- •climate, or has used tanning booths within 4 weeks prior to Day 1 or is not
- •willing to minimize natural and artificial sunlight exposure during the study.
- •Use of sunscreen products (except on application areas) and protective apparel
- •are recommended when sun exposure cannot be avoided.
- •14. Subject has received laser treatment, electrolysis on the application areas
- •within 4 weeks prior to Day 1 or is planning to during the study period.
- •15. Subject has shaved the application area 72 hours prior to Day 1, or is
- •planning to do so during the study period.
- •16. Subject has used cannabis or any cannabinoid products within 12 weeks prior
- •17. Subject has used any medication known to impair alertness and/or ability to
- •detect discomfort within 1 week prior to Day 1.
- •18. Subject has used a topical applied treatment on the targeted application
- •area(s) within 1 week prior to Day 1.
- •19. Subject has a known history of clinically significant drug or alcohol abuse
- •in the last year prior to Day 1.
- •20. Subject has a positive screen result for drug of abuse at screening
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