NL-OMON51456已完成不适用
Study to evaluate the effects of intravenously administered LPS on the bone marrow immune cell compartment in healthy male volunteers - Bone marrow sampling to assess effects of i.v. LPS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Male participants between 18 and 35 years of age (inclusive), at the time of
- •signing the informed consent.
- •2. Participants who are overtly healthy as determined by medical evaluation
- •including medical history, physical examination, laboratory tests, and ECG.
- •3. A body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive), and a
- •minimum body weight of 50 kg.
- •4. Able to give written informed consent and willing to comply with all
- •study-related procedures.
排除标准
- •1. Clinically significant abnormalities, as judged by the investigator, in test
- •results (including physical examination, laboratory tests, ECG and vital signs).
- •2. History of medical conditions, which in the opinion of the investigator may
- •compromise participant*s safety or scientific value of the study, posing an
- •unacceptable risk to the participant or interfere with the participant's
- •ability to comply with study procedures or abide by study restrictions.
- •3. History of trauma with likely damage to the spleen or surgery to spleen, or
- •history of hip fracture or surgery in the pelvic area.
- •4. Previous participation in a systemic (i.v./inhaled) LPS challenge trial
- •within a year before the first study day.
- •5. Any active inflammatory or infectious disease (e.g., periodontitis), with
- •the exception of common viral or fungal skin infections such as plantar warts
- •or athlete*s foot.
- •6. Febrile illness within 30 days before the start of the first study day.
- •7. Antibiotic use, operation or intervention by surgeon/dentist within one
- •month before the first study day.
- •8. Hemorrhagic diathesis (easy bruising, epistaxis, gastro-intestinal bleeding,
- •history of serious bleeding).
- •9. Clinically significant hypertension (defined as systolic blood pressure >
- •145 mmHg or diastolic blood pressure > 90 mmHg, repeatedly measured after 5
- •minutes in resting supine position), or clinically significant hypotension
- •(defined as systolic blood pressure < 90 mmHg or diastolic blood pressure < 50
- •mmHg, repeatedly measured after 5 minutes in resting supine position);
- •10. Clinically significant abnormalities in the 12-lead ECG (QRS complex >
- •120ms, PR interval > 210ms, QTcF interval > 470ms).
- •11. Positive test results for hepatitis B, hepatitis C, HIV antibody or any
- •other obvious disease associated with immune deficiency.
- •12. Subjects with a positive urine drug screen/alcohol test result at screening
- •or first admission or a history of substance abuse in the last 12 months prior
- •to the start of the study.
- •13. Subjects who smoke more than 6 cigarettes or the equivalent in tobacco per
- •day and are unwilling to abstain from smoking during the study period (from
- •screening until EOS).
- •14. Loss or donation of blood over 500 mL within 3 months prior to screening or
- •donation of plasma within 14 days prior to screening.
- •15. Participation in an investigational drug or device study within 3 months
- •between last dosing in previous study and admission to the CRU in present study
- •or more than 4 times in the past year.
- •16. Any vaccination within the last 3 months; COVID-19 vaccination (or
- •infection as confirmed by a PCR test) is allowed up until 4 weeks prior to
- •admission to the CRU; COVID-19 booster vaccination is allowed up until 2 weeks
- •prior to admission to the CRU.
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