Immunometabolism Energy management of the immune system
Conditions
Interventions
LPS is a small part of a bacterium and is often used to study the immune system in people. When you receive LPS, you may feel a bit sick. This means your immune system is activated.Aldesleukin is a na
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Healthy male and female participants, 18 to 45 years of age, inclusive at screening. 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, blood serology and urinalysis. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy participants.Body mass index (BMI) between 18 and 30 kg/m2 and a minimum weight of 50 kg, inclusive; Women of childbearing potential must use effective contraception for the full duration of the study and be willing and able to continue contraception for at least 15 days after their last dose of study treatment (no requirements for males and women of non-childbearing potential). Women of childbearing potential are defined as all women physiologically capable of becoming pregnant, unless they meet one of the following conditions: a. Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 weeks after surgical bilateral oophorectomy with or without hysterectomy; b. Post-hysterectomy. Has the ability to communicate well with the Investigator in the Dutch language, is able and willing to give written informed consent prior to any study-mandated procedure and to comply with the study restrictions.
Exclusion criteria
Exclusion criteria: Participation in a systemic (e.g. intravenous, inhaled) or local local (e.g. intradermal, intranasal) LPS challenge trial within a year prior to the baseline visit; Use of immunosuppressive or immunomodulatory medication within 30 days prior to enrolment or planned to use during the course of the study; Use of any medications (prescription or over-the-counter [OTC]), within 14 days of study drug administration, or less than 5 half-lives (whichever is longer). Exceptions are paracetamol (up to 4 g/day). Other exceptions will only be made if the rationale is clearly documented by the investigator; (History of) autoimmune disease such as multiple sclerosis, inflammatory bowel disease, rheumatoid arthritis or other immune-inflammatory diseases; Presence of current or a history of ongoing, chronic or recurrent infections or infectious disease, unless if judged to be clinically irrelevant by the investigator;For part B only: A Body Surface Area (BSA) of > 2 m2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Studying what happens inside immune cells when they get “switched on”Studying the substances that immune cells produce when they are “switched on”Studying which immune cells get “switched on” | — |
Secondary
| Measure | Time frame |
|---|---|
| Studying how safe IL-2 is and how well people tolerate itLooking at how cells change their activity and use energy after the treatments | — |
Countries
Netherlands
Contacts
Public ContactM.M. Moerland
Centre for Human Drug Research
Outcome results
None listed