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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07313150
Eligibility Criteria:
Inclusion Criteria:
Aged between 18 and 55 years (inclusive) Physical examination, vital signs, laboratory tests, 12-lead ECG, and imaging findings are within normal ranges.
Body weight ≥50 kg for males and ≥45 kg for females, with a BM) between 18.0 and 28 kg/m² (inclusive).
Willing or has complied with the administration of meningococcal and pneumococcal vaccines as required by the protocol.
No plan to donate sperm or ova, no pregnancy plan, and voluntarily agrees to use effective contraception methods from the signing of the ICF until 12 months after administration of the investigational product.
Able to understand and comply with the study procedures, voluntarily participate in the trial, and provide written informed consent.
Exclusion Criteria:
History of food or drug allergy, and/or known allergy to GalNAc. History of definite infection with encapsulated bacteria within 6 months prior to screening.
History of recurrent or chronic infection within 3 months prior to screening. Presence or suspicion of active viral, bacterial, fungal, or parasitic infection within 1 month prior to baseline.
Any disease at screening that, in the investigator's judgment, could affect the study data.
History of malignancy. Any condition that may affect drug absorption. History of splenectomy or congenital asplenia. History of congenital or acquired complement deficiency or disorder. History of allergic diseases (e.g., allergic asthma, allergic rhinitis).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT07313150
Study Brief:
Protocol Section:
NCT07313150