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Completed Phase 1 Interventional Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT04165837

Public ClinicalTrials.gov record NCT04165837. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 9, 2026, 8:52 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral FB-101 in Healthy Subjects

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of oral doses of FB-101 in healthy subjects.

Study identification

NCT ID
NCT04165837
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
1ST Biotherapeutics, Inc.
Industry
Enrollment
24 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
19 Years to 55 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 14, 2019 (Actual)
Primary completion
Nov 12, 2021 (Actual)
Completion
Jul 14, 2022 (Actual)
Last update posted
Jan 26, 2023

2019 – 2022

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
PAREXEL Baltimore Maryland 21225 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04165837, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 26, 2023 · Synced Oct 9, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04165837 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →