Actively Recruiting
A Phase 1, SAD and MAD Study to Evaluate the Safety and Tolerability of FB418
Led by 1ST Biotherapeutics, Inc. · Updated on 2024-12-02
64
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 1, SAD and MAD Study to Evaluate the Safety and Tolerability of FB418
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adult males aged 19 to 55 years at screening
- Healthy elderly males or females (non-childbearing potential) aged 60 years or older at screening for Part A Cohort 5
- For elderly participants, must be able to stop taking existing drugs at least 2 weeks before the first dose or before five half-lives of those drugs
- Continuous non-smokers who have not used nicotine-containing products for at least 3 months prior to and throughout the study
- Body mass index (BMI) between 18 and 32 kg/m2 at screening
- Medically healthy with no clinically significant medical history, physical examination, neurological examination, lab profiles, vital signs, or ECG abnormalities as judged by the investigator
- Female subjects in Cohort 5 must be of non-childbearing potential
You will not qualify if you...
- Mentally or legally incapacitated or with significant emotional problems at screening or expected during the study
- History or presence of clinically significant medical or psychiatric conditions as judged by the investigator
- Any illness that could affect study results or increase risk to the participant
- Suicidal risk including attempts within 12 months or suicidal ideation within 3 months prior to screening
- History or presence of alcoholism or drug abuse within 2 years prior to dosing
- Hypersensitivity or reaction to the study drug or related compounds
- History of seizures (except childhood febrile seizures)
- Positive urine drug or alcohol test at screening or check-in
- Abnormal ECG with second- or third-degree AV block, prolonged QRS, QTcF, or PR intervals, or any clinically significant arrhythmia
- Medical or surgical conditions contraindicating lumbar puncture as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Seoul National University
Seoul, South Korea, 03080
Actively Recruiting
Research Team
1
1STBIO information team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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