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

NCT05995782 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-12-02

No results posted yet for this study

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.

Conditions

  • Parkinson Disease Psychosis
  • Amyotrophic Lateral Sclerosis (ALS)

Interventions

DRUG

FB418

Oral dose

Sponsors & Collaborators

  • 1ST Biotherapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • 1STBIO study manager · 1ST Biotherapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-20
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05995782 on ClinicalTrials.gov