NCT05995782
A Phase 1, SAD and MAD Study to Evaluate the Safety and Tolerability of FB418
Recruiting · Phase 1 · 1ST Biotherapeutics, Inc. · registry updated 2024-12-02
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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.
Exclusion
- 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.
- Is at suicidal risk in the opinion of the PI as per the following criteria:
- Any suicide attempts within 12 months prior to screening or any suicidal intent, including a plan, within 3 months prior to screening.
- C-SSRS answer of "YES" on suicidal ideation within 3 months prior to screening.