Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05995782

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

Amyotrophic Lateral Sclerosis (ALS) Clinical Trial

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

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05995782
Study type Interventional
Source 1ST Biotherapeutics, Inc.
Contact 1STBIO information team
Phone +82-31-895-4677
Email info@1stbio.com
Status Not yet recruiting
Phase Phase 1
Start date December 2023
Completion date December 2024
View Details
See also
  Status Clinical Trial Phase
Completed NCT02365922 - Advancing Research and Treatment for Frontotemporal Lobar Degeneration (ARTFL)
Completed NCT01699451 - DNA, Blood and Skin Cell Repository for Research on ALS and Related Neurodegenerative Disorders at Mayo Clinic Florida
Completed NCT04577404 - Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS) Phase 3
Terminated NCT03580616 - Tolerability and Efficacy of L-Serine in Patients With Amyotrophic Lateral Sclerosis (ALS) Phase 2
Completed NCT01884571 - Immunosuppression in Amyotrophic Lateral Sclerosis (ALS) Phase 2
Completed NCT02118805 - Innovative Measures of Speech and Swallowing Dysfunction in Neurological Disorders
Completed NCT00244244 - A Multicenter, Dose Ranging Safety and Pharmacokinetics Study of Arimoclomol in ALS Phase 2
Active, not recruiting NCT00420719 - Motor-Point Stimulation for Conditioning the Diaphragm of Patients With Amyotrophic Lateral Sclerosis (ALS) N/A
Completed NCT02936635 - A Study for Patients Who Completed VITALITY-ALS (CY 4031) Phase 3
Withdrawn NCT04055532 - Biomarkers in Neurodegenerative Diseases
Completed NCT03645031 - Acute Intermittent Hypoxia and Breathing in Neuromuscular Disease N/A
Completed NCT01786603 - Rasagiline in Subjects With Amyotrophic Lateral Sclerosis (ALS) Phase 2
Completed NCT02559869 - Imaging and BioFluid Biomarkers in Amyotrophic Lateral Sclerosis
Completed NCT01592552 - A Biospecimen and Clinical Data Study on Patients for Drug & Biomarker Discovery
Completed NCT00403104 - Placebo Controlled Study of ONO2506PO in the Presence of Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS) Phase 2
Recruiting NCT02424669 - Neuroinflammation in Amyotrophic Lateral Sclerosis - Mechanisms and Therapeutic Perspectives: a Translational Pilot Study Among ALS Patients N/A
Completed NCT02017912 - Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study of Autologous MSC-NTF Cells in Patients With ALS Phase 2
Completed NCT01366027 - PRISM Registry: Pseudobulbar Affect Registry Series N/A
Completed NCT00330681 - Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) Phase 3
Completed NCT00876772 - Olanzapine for the Treatment of Appetite Loss in Amyotrophic Lateral Sclerosis (ALS) Phase 2/Phase 3