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:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 12:53 AM
NCT ID:
NCT06115967
Eligibility Criteria:
Inclusion Criteria:
* Females must have a negative pregnancy test.
* Contraceptive use by males and females should be consistent with local regulations.
* Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg.
* For optional Japanese participants only:
* Participants must be of Japanese descent defined as: first generation (born to 2 Japanese parents and 4 Japanese grandparents).
* Born in Japan, and not have lived outside Japan for more than 5 years.
* Lifestyle, including diet, must not have significantly changed since leaving Japan.
Exclusion Criteria:
* History of any clinically important disease or disorder.
* Current or recurrent disease of clinical significance that could affect clinical assessments or clinical laboratory evaluations.
* Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of study intervention.
* History of congenital or acquired immunodeficiency or complement deficiency or an underlying condition that predisposes to infection.
* History of any Neisseria infection, unexplained, recurrent infections, or infection requiring treatment with systemic antibiotics.
* Evidence of hepatitis B infection (positive for HBsAg or positive for anti-HBcAb) or hepatitis C viral infection (HCV Abs or hepatitis C RNA positive) or HIV infection (positive for HIV type 1 or type 2 Abs).
* Participants testing positive for COVID-19 prior to dosing.
* Any cardiac abnormalities.
* A CAP activity \< 60% at screening.
* Known or suspected history of drug abuse, history of alcohol abuse or smoking.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT06115967
Study Brief:
Protocol Section:
NCT06115967