A Phase 1 interventional study of FB418 in Parkinson Disease Psychosis and Amyotrophic Lateral Sclerosis (ALS), sponsored by 1ST Biotherapeutics, Inc.. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-02.
Sponsored by 1ST Biotherapeutics, Inc. · Phase 1, Interventional, and Treatment
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.
Part A:
Primary:
To assess the safety and tolerability of single ascending oral doses of FB418 in healthy adult subjects and healthy elderly subjects.
Secondary:
To assess the pharmacokinetics (PK) of FB418 and metabolite after single ascending oral doses of FB418 in healthy adult subjects and healthy elderly subjects.
To assess the effect of a high-fat meal on the PK of FB418 and metabolite after a single oral dose of FB418 when administered to healthy adult subjects.
Part B:
Primary:
To assess the safety and tolerability of multiple ascending oral doses FB418 in healthy adult subjects.
Secondary:
To assess the PK of FB418 and metabolite after multiple ascending oral doses of FB418 in healthy adult subjects.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 64 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →1ST Biotherapeutics, Inc. is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Is at suicidal risk in the opinion of the PI as per the following criteria:
Part A - Single ascending oral doses of FB418 in healthy adult subjects and healthy elderly subjects. Part B - Multiple ascending oral doses FB418 in healthy adult subjects.
Drug: FB418
Part A - Single Ascending Dose matching placebo study Part B - Multiple Ascending Dose matching placebo study
Drug: FB418
Oral dose
Also known as: FB418 active drug
Treatment Emergent Adverse Events (TEAE)
Number of TEAEs including serious adverse events (SAEs)
Time frame: Up to 7 ~ 14 days after the last dose
PK parameter 1
Maximum observed concentration (Cmax) of FB418 in plasma
Time frame: Up to 72 hours after the last dose
PK parameter 2
Time to maximum observed concentration (Tmax) of FB418 in plasma
Time frame: Up to 72 hours after the last dose
PK parameter 3
The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of FB418 in plasma
Time frame: Up to 72 hours after the last dose
PK parameter 4
Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC\[0-last\]) of FB418 in plasma
Time frame: Up to 72 hours after the last dose
PK parameter 5
Apparent terminal elimination half-life (t1/2) of FB418 in plasma
Time frame: Up to 72 hours after the last dose
Plan to share: No
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1ST Biotherapeutics, Inc.