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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

Key Inclusion Criteria: 1. Healthy, adult, male 19 55 years of age, inclusive, at the screening. 2. 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. 3. 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) 4. 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. 5. Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2 at the screening. 6. 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. 7. In Cohort 5, A female subject must be of non childbearing potential Key Exclusion Criteria: 1. 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. 2. History or presence of a clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee. 3. 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. 4. Is at suicidal risk in the opinion of the PI as per the following criteria: 1. Any suicide attempts within 12 months prior to screening or any suicidal intent, including a plan, within 3 months prior to screening. 2. C-SSRS answer of "YES" on suicidal ideation within 3 months prior to screening. 5. History or presence of alcoholism or drug abuse within the past 2 years prior to (the first) dosing. 6. History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds. 7. History of seizures (childhood febrile seizures are excepted). 8. Positive urine drug or alcohol results at screening or check in. 9. Has an abnormal screening ECG indicating a second- or third- degree AV block, or one or more of the following: QRS \> 120 msec, QTcF \> 450 msec for males and \> 460 msec for females, PR interval \> 220 msec. Any rhythm other than normal sinus rhythm, which is interpreted by the PI or designee to be clinically significant at screening or check-in. 10. Has any medical or surgical condition in which lumbar puncture is contraindicated in the opinion of the PI.
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

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.

Further description from the registry

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.

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.

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

Recruiting

Jang Injin, M.D · ijjang@snu.ac.kr

Facility not reported

Korea, Republic of

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.