NL-OMON48081已完成不适用
A randomized, double-blind, double-dummy, placebo-controlled, 3-way crossover proof of concept study of intradermally administered desmopressin in healthy volunteers using a nanoporous microneedle array. - Dose ranging study of intradermal desmopressin.
MyLife Technologies0 个研究点目标入组 6 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
- 6
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. Healthy male or non-pregnant female subjects, 18 to 65 years of age
- •(inclusive). (Healthy status is defined by absence of evidence of any clinical
- •significant/uncontrolled active or chronic disease following a detailed medical
- •and surgical history, a complete physical examination including vital
- •signs,12-lead ECG, hematology, blood chemistry, serology and urinalysis);
- •2. Free of any polyuric disease (e.g., central diabetes insipidus), hemophilia
- •or Von Willebrand disease;
- •3. Body mass index (BMI) between 18 and 35 kg/m2, inclusive;
- •4. Free of clinically significant systemic or dermatologic disorders, which, in
- •the opinion of the investigator, will interfere with the study results or
- •increase the risk of Adverse Events;
- •5. If female of childbearing potential have a negative urine pregnancy test at
- •Screening/Day 0, and is willing to use effective contraception during the study
- •(i.e., oral, implanted, injectable, IUD, diaphragm, condom, tubal ligation,
- •abstinence, or are in a monogamous relationship with a partner who has had a
- •vasectomy);
- •6. Suitable site for intradermal injection, patch application on the arms, as
- •assessed by the investigator;
- •7. Fitzpatrick skin type I-II (Caucasian);
- •8. Able to participate and willing to give written informed consent and to
- •comply with the study restrictions;
- •9. Ability to communicate well with the investigator in the Dutch language;
排除标准
- •Eligible subjects must meet none of the following exclusion criteria:
- •1. Any clinically significant abnormality as determined by medical history
- •taking and physical examinations obtained during the screening visit that in
- •the opinion of the investigator would interfere with the study objectives or
- •compromise subject safety;
- •2. Not willing to use effective (double barrier) contraception until at least 3
- •months after last study drug application;
- •3. For women: a positive pregnancy test and/or breastfeeding at screening or
- •women who plan to become pregnant;
- •4. A positive test for drugs of abuse at screening;
- •5. History of alcohol or illicit drug abuse (alcohol abuse defined as alcohol
- •consumption > 21 units/week);
- •6. Positive test results for Hepatitis B, Hepatitis C or HIV;
- •7. Have any current and / or recurrent clinical significant skin infection in
- •the treatment area;
- •8. Have a known sensitivity to any of the investigational product ingredients;
- •9. Participation in an investigational drug or device study within 3 months
- •prior to screening or more than 4 times in the past year;
- •10. Donation of blood or blood loss of >500 mL within 3 months prior to
- •screening or donation of plasma within 14 days;
- •11. Not having a general practitioner;
- •12. Not willing to give permission to have the general practitioner to be
- •notified upon participation in this study;
- •13. Any condition that in the opinion of the investigator would complicate or
- •compromise the study or the well-being of the subject.
研究者
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