Health TrialsbyHealthPanel

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

ConditionsParkinson Disease PsychosisAmyotrophic Lateral Sclerosis (ALS)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
Sponsor1ST Biotherapeutics, Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Any suicide attempts within 12 months prior to screening or any suicidal intent, including a plan, within 3 months prior to screening.

Trial design

Design model

Parallel

Treatments tested in this trial

  • FB418

    Drug

    Oral dose

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: FB418Experimental treatment 1 intervention
Group B: FB418-PlaceboPlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

1ST Biotherapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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