Actively Recruiting
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, SAD and MAD Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral FB418 in Healthy Adult and Elderly Subjects
Led by 1ST Biotherapeutics, Inc. · Updated on 2024-12-02
64
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and how the body processes (pharmacokinetics and pharmacodynamics) a drug called FB418 in healthy adults and elderly individuals. This Phase 1 trial involves healthy people aged 19 and older, including a specific group of elderly participants, to understand how different doses affect safety and drug behavior in the body. The study has two parts: Part A tests single increasing oral doses of FB418 in both healthy adults and elderly subjects, including examining how a high-fat meal affects the drug's absorption. Part B involves giving multiple increasing oral doses to healthy adults to further assess safety and drug behavior. Both parts include a placebo group for comparison, and dosing schedules are carefully controlled and monitored. Participants will undergo screening to confirm health status and eligibility, followed by dosing and monitoring periods lasting from a few days up to two weeks after the last dose. Researchers will measure adverse events and detailed drug levels in the body up to 72 hours after dosing. Safety assessments include physical exams, blood tests, ECGs, and neurological evaluations. The study's total duration per participant varies according to dosing and follow-up requirements.
CONDITIONS
Brief 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 (Part A Cohort 5 only)
- Elderly participants with mild disease history may participate if medication can be stopped at least 2 weeks before dosing or based on drug half-life
- Continuous non-smokers who have not used nicotine products for at least 3 months prior to dosing 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 exam, neurological exam, lab tests, vital signs, or ECG abnormalities as determined by the investigator
- Females in Cohort 5 must be of non-childbearing potential
You will not qualify if you...
- Mentally or legally incapacitated or having 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 plans within 3 months prior to screening
- Positive suicidal ideation within 3 months prior to screening
- History or presence of alcoholism or drug abuse within 2 years before dosing
- Known hypersensitivity or reaction to the study drug or related compounds
- History of seizures (except childhood febrile seizures)
- Positive urine drug or alcohol tests at screening
- Abnormal ECG showing second- or third-degree AV block, prolonged QRS, QTcF, PR interval, or other clinically significant rhythm abnormalities
- Medical or surgical conditions contraindicating lumbar puncture as per investigator's opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 14 days after the last dose
Participants receive single or multiple ascending oral doses of FB418 or placebo to assess safety, tolerability, and pharmacokinetics.
Trial Site Locations
Total: 1 location
1
Seoul National University
Seoul, South Korea, 03080
Actively Recruiting
Research Team
1
1STBIO information team
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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