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 @ 5:41 PM
Ignite Modification Date:
2025-12-24 @ 5:41 PM
NCT ID:
NCT05095168
Eligibility Criteria:
Inclusion Criteria:
* Subjects must be able to understand and provide informed consent.
* Males or females, between 21 and 45 years of age, inclusive;
* Body mass index must be within the range of 18.5 to 32.0 kg/m2;
* 12-lead electrocardiogram (ECG) within normal limits with no clinically significant abnormalities in the opinion of the Investigator；
* Systolic blood pressure ≤140 mmHg and a diastolic blood pressure of ≤ 90 mmHg after 5 minutes with supine rest；
* non-pregnancy
* meningococcal vaccinations for at least 2 weeks before dosing
Exclusion Criteria:
* Disease or conditions interfere with participating the trial
* Active serious mental illness or psychiatric disorder
* clinically relevant abnormal test results in hepatic function
* unacceptable CBC lab test
* asymptomatic complement deficiency
* Any other clinical safety laboratory test
* HIV, HBV, HCV positive
* Alcohol and drug abuse
* etc.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
45 Years
Study:
NCT05095168
Study Brief:
Protocol Section:
NCT05095168