Study to evaluate the effects of intravenously administered LPS on the bone marrow immune cell compartment in healthy male volunteers
- Conditions
- Oncologyautoimmune disorderscancerinflammatory disorders10027665
- Registration Number
- NL-OMON51456
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 13
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.
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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method