Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT05817435
Eligibility Criteria:
Inclusion Criteria:
* Is at least the local legal age of consent for participation in a clinical study and ≤55 years when signing the ICF
* Is capable of providing signed informed consent, and complying with protocol requirements
* Agrees to use contraceptive measures consistent with local regulations and the following: Women Of Child-Bearing Potential must have a negative serum hCG pregnancy test at screening and a negative urine hCG pregnancy test at baseline before receiving IMP.
* Has a BMI between 18 and 30 kg/m2 , inclusive, and a weight between 50 and 100 kg (inclusive) at screening
Exclusion Criteria:
* Has a known autoimmune disease or any medical condition that, in the investigator's judgment, would interfere with an accurate assessment of clinical symptoms or puts the participant at undue risk
* Has a history of malignancy, unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years before the administration of IMP. Adequately-treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological findings of prostate cancer.
* Has a clinically significant active infection that is not sufficiently resolved in the investigator's opinion.
* Has a positive serum test at screening for active infection with any of the following: HBV indicative of an acute or chronic infection, unless associated with a negative HBsAg or negative HBV DNA test; HCV based on HCV antibody assay unless a negative RNA test is available ; HIV based on test results (regardless of therapy treatment or not).
* Has a clinically significant disease, recent major surgery (within 3 months of screening), or intends to have surgery during the study; or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk.
* Received a different IMP in another clinical study \<12 weeks or 5 half-lives (whichever is longer) before screening.
* Is currently participating in another interventional clinical study. Has a known hypersensitivity to IMP or its excipients.
* Has abdominal skin condition that does not allow for absorption and assessment of local safety of the planned SC injection, as determined by the investigator.
* Has a history of (within 12 months before screening) or current alcohol, drug, or medication abuse, as assessed by the investigator.
* Is pregnant or lactating or intends to become pregnant during the study.
* Previously participated in an efgartigimod clinical study and received at least 1 dose of IMP.
* Is taking concomitant medications (except for oral contraceptives or occasional acetaminophen).
* Has a total IgG of \<4 g/L at screening.
* Had a positive COVID-19 test result on day -1 or contact with someone with a known COVID-19 infection within 2 weeks before receiving IMP.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT05817435
Study Brief:
Protocol Section:
NCT05817435