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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| FB418-Placebo | Placebo Comparator | Part A - Single Ascending Dose matching placebo study Part B - Multiple Ascending Dose matching placebo study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FB418 | Drug | Oral dose |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Emergent Adverse Events (TEAE) | Number of TEAEs including serious adverse events (SAEs) | Up to 7 ~ 14 days after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter 1 | Maximum observed concentration (Cmax) of FB418 in plasma | Up to 72 hours after the last dose |
| PK parameter 2 | Time to maximum observed concentration (Tmax) of FB418 in plasma |
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Key Inclusion Criteria:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 1STBIO information team | Contact | +82-31-895-4677 | info@1stbio.com |
| Name | Affiliation | Role |
|---|---|---|
| 1STBIO study manager | 1ST Biotherapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University | Recruiting | Seoul | 03080 | South Korea |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| 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 | 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 | Up to 72 hours after the last dose |
| PK parameter 5 | Apparent terminal elimination half-life (t1/2) of FB418 in plasma | Up to 72 hours after the last dose |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |