NL-OMON38993已完成不适用
An open label, single dose study to assess the pharmacokinetics of a microdose of recombinant human placental alkaline phosphatase (hRESCAP, part 1) followed by a randomized, double-blind, placebo-controlled, parallel, single ascending dose, first-in-human study to assess safety and tolerability of hRESCAP (part 2) in healthy male volunteers - PK, safety and tolerability of hRESCAP in healthy male volunteers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
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 subjects, 18 - 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, 12-lead ECG, haematology, blood chemistry, and urinalysis;
- •2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive;
- •3. Ability to communicate well with the investigator in the Dutch language;
- •4. Able to participate and willing to give written informed consent and to comply with the study restrictions;
- •5. Venous access sufficient to allow blood sampling as per protocol.
排除标准
- •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. History of a surgical event that may significantly affect the study outcome;
- •3. History of allergy or other inflammatory indications;
- •4. History of asthma or other inflammatory disease;
- •5. Use of prescription medications within 21 days prior to study drug administrations, or less than 5 half-lives, whichever is longer, and during the course of the study.
- •6. Alkaline Phosphatase levels in plasma of < 30 IU/L or > 115 IU/L;
- •7. Clinically relevant abnormal laboratory results, ECG, vital signs, or physical findings at screening that in the opinion of the investigator would interfere with the study objectives or compromise subject safety;
- •8. Participation in an investigational drug study within 3 months prior to screening or more than 4 times in the past year;
- •9. Any psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol;
- •10. History of alcohol or illicit drug abuse (alcohol abuse defined as alcohol consumption > 28 units/week);
- •11. Reported unexplained weight loss or weight gain of > 2 kg in the month prior to screening;
- •12. Positive test results for Hepatitis B, Hepatitis C or HIV;
- •13. Donation of blood within 3 months prior to screening or donation of plasma within 14 days prior to screening;
- •14. Not having a general practitioner;
- •15. Not willing to accept information transfer which concerns participation in the study, or information regarding health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner;
- •16. Not willing to give permission to have the general practitioner to be notified upon participation in this study;
- •17. Prior participation in part 1 for subjects participating in part 2 of the study;
- •18. Not willing to use effective (double barrier) contraception until at least 3 months after dose administration.
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