auto immune diseases disease in which the immune system attacks its own body
Conditions
Interventions
the volunteer will be given efgartigimod or placebo as an intravenous infusion
(solution of the compound that will be administered directly in a blood
vessel). The infusion takes 1 hour.
The Pneum
open-label study.
The study compound will be given 4 times: on Day 1, 8, 15, and 22. Depending on
what group the volunteer is in, the Pneumovax 23 vaccine will be given either
prior to the last ad
Sponsors
Argenx BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. At least18 years of age at the time of signing the informed consent form (ICF) 2. Healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring 3. Body mass index (BMI) between 18 kg/m2 to 30 kg/m2 (inclusive) 4. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 5. Capable of giving signed informed consent as described in Appendix 1, Section 10.1.3, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol 6. Abstains from smoking for at least 3 months prior to screening 7. Negative urine drug screen (amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, and tricyclic antidepressants) at screening and on day -1 8. Negative alcohol urine test at screening and on day -1 9. Agrees to restrict excessive strenuous physical activities 96 hours prior to screening, 96 hours prior to the visits in the treatment period (D-1, D7, D14, and D21), and 96 hours prior to the visits in follow-up period
Exclusion criteria
Exclusion criteria: 1. Clinically significant active or chronic bacterial, viral, including or fungal infection at day -1 2. History of malignancy unless deemed cured by adequate treatment with no evidence of recurrence for >=3 years before the first administration of study intervention. Participants with the following cancers can be included at any time: a. Adequately treated basal cell or squamous cell skin cancer b. Carcinoma in situ of the cervix c. Carcinoma in situ of the breast d. Incidental histological finding of prostate cancer (TNM stage T1a or T1b) 3. Clinical evidence of other significant serious diseases, a recent major surgery, or any other condition that, in the opinion of the investigator, could confound the results of the study or put the participant at undue risk 4. Use of an investigational product within 2 months or 5 half-lives (whichever is longer) before the first dose of study intervention 5. Use of any monoclonal antibody within 3 months prior to the initial study intervention administration For more exclusion criteria see the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the humoral immune response to the PNEUMOVAX 23 vaccine in healthy participants receiving efgartigimod intravenously (IV) | — |
Secondary
| Measure | Time frame |
|---|---|
| - To evaluate the safety and tolerability of efgartigimod IV in healthy participants vaccinated with PNEUMOVAX 23 | — |
Countries
Netherlands
Outcome results
None listed