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RecruitingNCT05995782Updated Dec 2, 2024

A Phase 1, SAD and MAD Study to Evaluate the Safety and Tolerability of FB418

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

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Dec 2023; still recruiting 2 years 9 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Parkinson Disease Psychosis
  • Amyotrophic Lateral Sclerosis (ALS)
03

In context

Parkinson Disease

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
64 participants (estimated)

Study arms

  • Experimental
    FB418

    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

  • Placebo comparator
    FB418-Placebo

    Part A - Single Ascending Dose matching placebo study Part B - Multiple Ascending Dose matching placebo study

    Drug: FB418

Interventions

  • DrugFB418

    Oral dose

    Also known as: FB418 active drug

06

What researchers measure

Primary outcomes

  1. Treatment Emergent Adverse Events (TEAE)

    Number of TEAEs including serious adverse events (SAEs)

    Time frame: Up to 7 ~ 14 days after the last dose

Secondary outcomes

  1. PK parameter 1

    Maximum observed concentration (Cmax) of FB418 in plasma

    Time frame: Up to 72 hours after the last dose

  2. PK parameter 2

    Time to maximum observed concentration (Tmax) of FB418 in plasma

    Time frame: Up to 72 hours after the last dose

  3. 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

  4. 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

  5. PK parameter 5

    Apparent terminal elimination half-life (t1/2) of FB418 in plasma

    Time frame: Up to 72 hours after the last dose

07

Study locations

1 of 1 sites recruiting
  • Seoul National University
    Seoul, 03080, Korea, Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05995782
Lead sponsor
1ST Biotherapeutics, Inc.
Responsible party
Sponsor
First posted
Aug 16, 2023
Start date
Dec 20, 2023
Primary completion
Dec 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Dec 2, 2024

Study contacts

1STBIO information team
Contact
info@1stbio.com
+82-31-895-4677
1STBIO study manager
study director · 1ST Biotherapeutics, Inc.

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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