MedPath

1ST Biotherapeutics, Inc.

1ST Biotherapeutics, Inc. logo
🇰🇷South Korea
Ownership
Holding
Established
2016-01-01
Employees
11
Market Cap
-
Website
http://www.1stbio.com

Clinical Trials

4

Active:0
Completed:1

Trial Phases

2 Phases

Phase 1:3
Not Applicable:1

Drug Approvals

0

Drug Approvals

No drug approvals found

This company may not have drug approvals in our database

Clinical Trials

Distribution across different clinical trial phases (4 trials with phase data)• Click on a phase to view related trials

Phase 1
3 (75.0%)
Not Applicable
1 (25.0%)

A Phase 1, SAD and MAD to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral FB-101 in Healthy Adult Male Subjects

Not Applicable
Not yet recruiting
Conditions
Healthy
Interventions
Drug: Placebo for FB-101
First Posted Date
2025-08-17
Last Posted Date
2025-08-17
Lead Sponsor
1ST Biotherapeutics, Inc.
Target Recruit Count
72
Registration Number
NCT07126704
Locations
🇰🇷

Seoul National University Hospital, Seoul, Korea, Republic of

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

Phase 1
Recruiting
Conditions
Amyotrophic Lateral Sclerosis (ALS)
Parkinson Disease Psychosis
Interventions
First Posted Date
2023-08-16
Last Posted Date
2024-12-02
Lead Sponsor
1ST Biotherapeutics, Inc.
Target Recruit Count
64
Registration Number
NCT05995782
Locations
🇰🇷

Seoul National University, Seoul, Korea, Republic of

A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849

First Posted Date
2023-03-09
Last Posted Date
2025-08-17
Lead Sponsor
1ST Biotherapeutics, Inc.
Target Recruit Count
151
Registration Number
NCT05761223
Locations
🇺🇸

Cleveland Clinic, Cleveland, Ohio, United States

🇺🇸

Mary Crowley Cancer Research Center, Dallas, Texas, United States

🇺🇸

NEXT Oncology San Antonio, San Antonio, Texas, United States

and more 2 locations

Safety, Tolerability, and Pharmacokinetics of Oral FB-101 in Healthy Subjects

Phase 1
Completed
Conditions
Parkinson's Disease
Interventions
Drug: Placebo
First Posted Date
2019-11-18
Last Posted Date
2023-01-26
Lead Sponsor
1ST Biotherapeutics, Inc.
Target Recruit Count
24
Registration Number
NCT04165837
Locations
🇺🇸

PAREXEL, Baltimore, Maryland, United States

News

No news found

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.