Parkinson Disease PsychosisPhase 1NCT05995782
A Phase 1, SAD and MAD Study to Evaluate the Safety and Tolerability of FB418
A Phase 1 study testing FB418 in people with Parkinson Disease Psychosis and Amyotrophic Lateral Sclerosis (ALS), run by 1ST Biotherapeutics, Inc. at 1 site in South Korea.
Trial 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 more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease Psychosis, Amyotrophic Lateral Sclerosis (ALS)
- What is being tested?
- FB418
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Dec 2023to Dec 2024
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University
Seoul, 03080
Jang Injin, M.D, ijjang@snu.ac.kr
About this study
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
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.
- Being tested
- FB418
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FB418Drug
Also called FB418 active drug
Oral dose
| Study group | Role | What they receive |
|---|---|---|
| FB418 | Experimental | 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. Receives: Drug: FB418 |
| FB418-Placebo | Placebo comparator | Part A - Single Ascending Dose matching placebo study Part B - Multiple Ascending Dose matching placebo study Receives: Drug: FB418 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Events (TEAE)
Number of TEAEs including serious adverse events (SAEs)
Measured: Up to 7 ~ 14 days after the last dose
Secondary outcomes (5)
PK parameter 1
Maximum observed concentration (Cmax) of FB418 in plasma
Measured: Up to 72 hours after the last dose
PK parameter 2
Time to maximum observed concentration (Tmax) of FB418 in plasma
Measured: Up to 72 hours after the last dose
PK parameter 3
The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of FB418 in plasma
Measured: Up to 72 hours after the last dose
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
Measured: Up to 72 hours after the last dose
PK parameter 5
Apparent terminal elimination half-life (t1/2) of FB418 in plasma
Measured: Up to 72 hours after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start20 Dec 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 1ST Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 1STBIO study manager, Study director, 1ST Biotherapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995782
- Sponsor's protocol ID
- FB418_P101
- Status last verified
- Nov 2024
- First submitted
- 7 Aug 2023
- Last updated
- 2 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05995782
- Acronym / sponsor ID
- FB418_P101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- 1ST Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FB418 | Experimental | Drug: FB418Part 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. |
| FB418-Placebo | Placebo comparator | Drug: FB418Part A - Single Ascending Dose matching placebo study Part B - Multiple Ascending Dose matching placebo study |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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:
- History or presence of alcoholism or drug abuse within the past 2 years prior to (the first) dosing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FB418Also: FB418 active drugOral dose | Drug | FB418, FB418-Placebo |
Primary outcome
Treatment Emergent Adverse Events (TEAE)
Time frame: Up to 7 ~ 14 days after the last dose
Number of TEAEs including serious adverse events (SAEs)
5 secondary outcomes
PK parameter 1
Time frame: Up to 72 hours after the last dose
PK parameter 2
Time frame: Up to 72 hours after the last dose
PK parameter 3
Time frame: Up to 72 hours after the last dose
PK parameter 4
Time frame: Up to 72 hours after the last dose
PK parameter 5
Time frame: Up to 72 hours after the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1STBIO study manager study director
1ST Biotherapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FB418 in people with Parkinson Disease Psychosis and Amyotrophic Lateral Sclerosis (ALS), run by 1ST Biotherapeutics, Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact 1STBIO information team (+82-31-895-4677, info@1stbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Emergent Adverse Events (TEAE) (time frame: Up to 7 ~ 14 days after the last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.