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 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT05521269
Eligibility Criteria:
Key Inclusion Criteria:
* Must be healthy as determined by medical evaluation including medical history, physical examination, vital signs assessments (including supine blood pressure, supine pulse rate, respiration rate, and temporal body temperature), 12-lead electrocardiogram (ECG), and laboratory tests.
* MAD cohorts only: Documented history of vaccinations within 5 years of Screening or willing to undergo vaccinations prior to Screening against encapsulated bacterial pathogens.
Key Exclusion Criteria:
* History or presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, malabsorption syndrome, metabolism, or elimination of drugs; constituting a risk when taking the study drug; or interfering with the interpretation of data. Exceptions can be made for individuals with childhood or remote disorders that are no longer active.
* History of any autoimmune disease
* History of meningitis or septicemia
* Clinically significant infection within 30 days prior to study drug administration that required medical intervention
* Known genetic deficiencies of the complement cascade system or immunodeficiency.
* Clinically significant illness within 4 weeks of the start of dose administration as determined by the Investigator.
* Clinically significant multiple or severe drug allergies, or severe post-treatment hypersensitivity reactions .
* History of prior other malignancy that could affect compliance with the protocol or interpretation of results
* Has clinically significant laboratory abnormalities or abnormal ECG
* History of splenectomy.
* Antinuclear antibodies titer ≥1:160 at Screening.
* Has donated blood or plasma within 30 days prior to Screening or had a loss of whole blood of more than 500 milliliter (mL) within the 30 days prior to Screening, or receipt of a blood transfusion within one year prior to Screening.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05521269
Study Brief:
Protocol Section:
NCT05521269