A Phase 1, SAD and MAD Study to Evaluate the Safety and Tolerability of FB418 (NCT05995782) | Clinical Trial Compass
RecruitingPhase 1
A Phase 1, SAD and MAD Study to Evaluate the Safety and Tolerability of FB418
South Korea64 participantsStarted 2023-12-20
Plain-language summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics and pharmacodynamics of oral doses of FB418 in healthy adult subjects and healthy elderly subjects.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Healthy, adult, male 19 55 years of age, inclusive, at the screening.
✓. For elderly subjects(Part A Cohort 5 only), healthy, elderly, male or female (of non childbearing potential only) over 60 years of age, inclusive, at screening.
✓. In the case of the elderly(Part A Cohort 5 only), they have a history of mild disease, but can participate if the researcher judges that they can stop taking the drug at least 2 weeks before the expected first dose or before the half-life is 5 times or more)
✓. The continuous non smoker who have not used nicotine containing products for at least 3 months prior to (the first) dosing and throughout the study are based on subjective self reporting.
✓. Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2 at the screening.
✓. Medically healthy with no clinically significant medical history, physical examination, simplified neurological examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
✓. In Cohort 5, A female subject must be of non childbearing potential
Exclusion criteria
✕. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
✕. History or presence of a clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
✕. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.