ISRCTN13536369进行中（未招募）Unknown
A study in healthy volunteers to evaluate the effect of repeated lipopolysaccharide skin challenges in a single individual
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 8
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
- •1. Healthy male and female subjects, 18 to 45 years of age, inclusive. Healthy status is defined by the absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, haematology, blood chemistry, blood serology and urinalysis. In the case of uncertain or questionable results, tests performed during screening may be repeated before enrollment to confirm eligibility or judged to be clinically irrelevant for healthy subjects.
- •2. Body mass index (BMI) between 18 and 30 kg/m² and a minimum weight of 50 kg, inclusive
- •3. Fitzpatrick skin type I-III (Caucasian)
- •4. Subjects and their partners of childbearing potential must use effective contraception for the duration of the study
- •5. Able and willing to give written informed consent and to comply with the study restrictions
排除标准
- •1. 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 the trial.
- •2. Any current and/or recurrent pathologically, clinically significant skin condition at the treatment area (lower arm and upper back, i.e., atopic dermatitis); including tattoos.
- •3. Requirement of immunosuppressive or immunomodulatory medication within 30 days prior to enrolment or planned to use during the course of the study.
- •4. Known immunodeficiency
- •5. Use of topical medication (prescription or over-the-counter [OTC]) in the local treatment area or any medication that may interfere with the study objectives as judged by the investigator within 30 days of study drug administration, or less than 5 half-lives (whichever is longer)
- •6. Participation in an investigational drug or device study within 3 months, or 5 half-lives whichever is longer, prior to screening or more than four times in the past year.
- •7. Loss or donation of blood over 500 ml within 3 months prior to screening or donation of plasma within 14 days of screening.
- •8. Any (medical) condition that would, in the opinion of the investigator, potentially compromise the safety or compliance of the patient or may preclude the patient’s successful completion of the clinical trial.
- •9. Pregnant, a positive pregnancy test, intending to become pregnant during the study conduct, or breastfeeding.
- •10. Positive hepatitis B surface antigen (HbsAg), hepatitis C antibody (HCV ab), or human immunodeficiency virus antibody (HIV ab) at screening.
- •11. A history of ongoing, chronic or recurrent infectious disease
- •12. Hypersensitivity for dermatological marker at screening
- •13. Current smoker and/or regular user of other nicotine-containing products (e.g., patches)
- •14. History of or current drug or substance abuse considered significant by the PI (or medically qualified designee), including a positive urine drug screen.
- •15. Presence of current, clinically relevant infections
- •16. Any vaccination within the last 4 weeks before day 1. Intention to receive any vaccination(s) before the last day of follow-up.
研究者
相似试验
已完成
不适用
A study in healthy volunteers to evaluate the effect of repeated LPS skin challenges in a single individualChallenge model developmentChallengeNL-OMON55995Hoffmann-La Roche8
撤回
不适用
A study in healthy volunteers to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of BN201, an investigational compound for the treatment of acute optic neuritis.inflammation of the optic nerve.10030061NL-OMON42731Bionure Pharma S.L. Barcelona32
已完成
1 期
A study in healthy volunteers to look at how different formulations (recipes) of the test medicine firibastat (QGC001) are taken up and broken down by the bodyISRCTN24120533Quantum Genomics (France)30
已完成
不适用
A clinical study in healthy volunteers to determine whether orally consumed tocopheryl phosphates are incorporated into oil produced/secreted by the skin.ACTRN12609000848202Phosphagenics Limited40
招募中
Unknown
Healthy female volunteer study to examine the effect of different body positions and environment on defecation physiologyConstipation - Dyssynergic defecationOral and Gastrointestinal - Normal oral and gastrointestinal development and functionACTRN12623000471684Royal North Shore Hospital - Northern Sydney Local Health District40