search
Back to results

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

Primary Purpose

Parkinson Disease Psychosis, Amyotrophic Lateral Sclerosis (ALS)

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
FB418
Sponsored by
1ST Biotherapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease Psychosis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Key Inclusion Criteria: Healthy, adult, male 19 55 years of age, inclusive, at the screening. 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. 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) 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. Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2 at the screening. 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. In Cohort 5, A female subject must be of non childbearing potential Key Exclusion Criteria: 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. History or presence of a clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee. 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. Is at suicidal risk in the opinion of the PI as per the following criteria: Any suicide attempts within 12 months prior to screening or any suicidal intent, including a plan, within 3 months prior to screening. C-SSRS answer of "YES" on suicidal ideation within 3 months prior to screening. History or presence of alcoholism or drug abuse within the past 2 years prior to (the first) dosing. History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds. History of seizures (childhood febrile seizures are excepted). Positive urine drug or alcohol results at screening or check in. 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. Has any medical or surgical condition in which lumbar puncture is contraindicated in the opinion of the PI.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    FB418

    FB418-Placebo

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    Treatment Emergent Adverse Events (TEAE)
    Number of TEAEs including serious adverse events (SAEs)

    Secondary Outcome Measures

    PK parameter 1
    Maximum observed concentration (Cmax) of FB418 in plasma
    PK parameter 2
    Time to maximum observed concentration (Tmax) of FB418 in plasma
    PK parameter 3
    The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of FB418 in plasma
    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
    PK parameter 5
    Apparent terminal elimination half-life (t1/2) of FB418 in plasma

    Full Information

    First Posted
    August 7, 2023
    Last Updated
    August 13, 2023
    Sponsor
    1ST Biotherapeutics, Inc.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05995782
    Brief Title
    A Phase 1, SAD and MAD Study to Evaluate the Safety and Tolerability of FB418
    Official 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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    September 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    1ST Biotherapeutics, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease Psychosis, Amyotrophic Lateral Sclerosis (ALS)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    64 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    FB418
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    FB418-Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Part A - Single Ascending Dose matching placebo study Part B - Multiple Ascending Dose matching placebo study
    Intervention Type
    Drug
    Intervention Name(s)
    FB418
    Other Intervention Name(s)
    FB418 active drug
    Intervention Description
    Oral dose
    Primary Outcome Measure Information:
    Title
    Treatment Emergent Adverse Events (TEAE)
    Description
    Number of TEAEs including serious adverse events (SAEs)
    Time Frame
    Up to 7 ~ 14 days after the last dose
    Secondary Outcome Measure Information:
    Title
    PK parameter 1
    Description
    Maximum observed concentration (Cmax) of FB418 in plasma
    Time Frame
    Up to 72 hours after the last dose
    Title
    PK parameter 2
    Description
    Time to maximum observed concentration (Tmax) of FB418 in plasma
    Time Frame
    Up to 72 hours after the last dose
    Title
    PK parameter 3
    Description
    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
    Title
    PK parameter 4
    Description
    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
    Title
    PK parameter 5
    Description
    Apparent terminal elimination half-life (t1/2) of FB418 in plasma
    Time Frame
    Up to 72 hours after the last dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Key Inclusion Criteria: Healthy, adult, male 19 55 years of age, inclusive, at the screening. 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. 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) 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. Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2 at the screening. 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. In Cohort 5, A female subject must be of non childbearing potential Key Exclusion Criteria: 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. History or presence of a clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee. 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. Is at suicidal risk in the opinion of the PI as per the following criteria: Any suicide attempts within 12 months prior to screening or any suicidal intent, including a plan, within 3 months prior to screening. C-SSRS answer of "YES" on suicidal ideation within 3 months prior to screening. History or presence of alcoholism or drug abuse within the past 2 years prior to (the first) dosing. History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds. History of seizures (childhood febrile seizures are excepted). Positive urine drug or alcohol results at screening or check in. 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. Has any medical or surgical condition in which lumbar puncture is contraindicated in the opinion of the PI.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    1STBIO information team
    Phone
    +82-31-895-4677
    Email
    info@1stbio.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    1STBIO study manager
    Organizational Affiliation
    1ST Biotherapeutics, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs