NL-OMON51456
Completed
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Oncology
- Sponsor
- Centre for Human Drug Research
- Enrollment
- 13
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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