Study to investigate the effects of different doses of lipopolysaccharide on immune cells in the blood and bone marrow of healthy young me

Not Applicable

Completed

• Conditions: Healthy volunteers; Not Applicable

• Registration Number: ISRCTN16913007
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-12-30
• Study Start: 2023-02-21
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 13

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 the participant’s safety or the scientific value of the study, posing an unacceptable risk to the participant or interfering 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 the 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, gastrointestinal 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, QTcFinterval > 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 of 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 the last dosing in the previous study and admission to the CRU in the 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 CR

Study & Design

• Study Type: Interventional
• Study Design: Not specified