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Tests treatment safety and results for Parkinson Disease Psychosis
Official title A Phase 1, SAD and MAD Study to Evaluate the Safety and Tolerability of FB418
ClinicalTrials.gov ID: NCT05995782
What this study is testing
What is FB418?
FB418 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for parkinson disease psychosis.
Also referred to as FB418 active drug.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older. Healthy volunteers may be eligible.
You may be able to join if
- Healthy, adult, male 19 55 years of age, inclusive, at the screening.
- For elderly people(Part A Cohort 5 only), healthy, elderly, male or female (of non childbearing potential only) over 60 years of age, inclusive, at...
- 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...
- 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...
- Body mass index (BMI) ≥ 18 and ≤ 32 kg/m2 at the screening.
You likely can't join if
- Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the...
- 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...
- 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.
See the full eligibility criteria
- Healthy, adult, male 19 55 years of age, inclusive, at the screening.
- For elderly people(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...
- 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
- 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...
- Has any medical or surgical condition in which lumbar puncture is contraindicated in the opinion of the PI.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.