Early safety testing of an experimental medicine in healthy adults
Researchers give single or repeated doses of FB418 to healthy adults, including older adults, to study safety and how the body handles it.
Testing a treatment or activity · Study reference: NCT05995782
Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓
This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.
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Looking for volunteers
- Start (reported actual date)
- 2023-12-20
- Main measurements finished (planned)
- 2024-12
- Study finished (planned)
- 2024-12
Planned dates can move. A study finishing does not tell us when a paper will be published.
No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.
Changes we have recorded
- 2026-10-11 — recruiting
These are dates we observed a change, not necessarily the dates it happened.
Papers connected to this study
No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.
Who can join?
Age 19 years and over · Also accepts healthy volunteers
These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.
Read all the rules for taking part
Sex eligibility reported by registry: all
Full study name & original research details
Official study title
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 Subjects and Healthy Elderly Subjects
Short title used by the registry
A Phase 1, SAD and MAD Study to Evaluate the Safety and Tolerability of FB418
Original description
Further description from the registry
Conditions reported: Parkinson Disease Psychosis; Amyotrophic Lateral Sclerosis (ALS)
Registry records for this study
Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.
- ClinicalTrials.gov · NCT05995782 ↗ — RECRUITING; checked 2026-10-13
- ClinicalTrials.gov · NCT05995782 ↗ — Recruiting; WHO ICTRP processed 2024-12-09; checked 2026-10-13
- Study type
- Interventional
- Interventions
- FB418
- Phases
- PHASE1
- Sponsor
- 1ST Biotherapeutics, Inc.
- Start date reported by registry
- 2023-12-20 (actual)
Registry updated: 2024-12-02 · Status last verified by the registry submitter: 2024-11
Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.
Contact the research team
Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.
1STBIO information team · +82-31-895-4677 · info@1stbio.com
Study locations
Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.
Seoul National University
Seoul, South Korea
RecruitingJang Injin, M.D · ijjang@snu.ac.kr
Facility not reported
Korea, Republic of
Status not reportedThe original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.