NL-OMON20584尚未招募不适用
Capsaicin pain model with topical 1% ethanolic capsaicin solution
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- CHDR
- 入组人数
- 10
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
入选标准
- •1. Healthy male subjects, 18 to 45 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs.
- •2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive.
- •3. Able to participate and willing to give written informed consent and to comply with the study restrictions.
排除标准
- •1. History or symptoms of any significant disease including (but not limited to), neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder.
- •2. Clinically significant abnormalities, as judged by the Investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis). In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects.
- •3. History of alcohol or drug abuse
- •4. Participation in an investigational drug or device study within 3 months prior to screening.
- •5. Any confirmed significant allergic reactions (urticaria or anaphylaxis) after previous exposure to capsaicin
- •6. Subject indicating intolerable pain after capsaicin administration at screening
- •7. Any current, clinically significant, known medical condition in particular any existing conditions that would affect sensitivity to cold (such as atherosclerosis, Raynaud’s disease, urticaria, hypothyroidism) or pain (i.e., disease that
- •causes pain, hypesthesia, hyperalgesia, allodynia, paraesthesia, neuropathy)
- •8. Subjects indicating pain tests intolerable at screening or achieving tolerance at >80% of maximum input intensity for any pain test for cold, pressure and electrical tests.
- •9. Dark skin (Fitzpatrick skin type V - VI), wide-spread acne, tattoos or scarring on the volar forearms.
研究者
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