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

NCT04165837 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-01-26

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

FB-101

Part A - Single Ascending Dose study Part B - Multiple Ascending Dose study

DRUG

Placebo

Part A - Single Ascending Dose matching placebo study Part B - Multiple Ascending Dose matching placebo study

Sponsors & Collaborators

  • 1ST Biotherapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-14
Primary Completion
2021-11-12
Completion
2022-07-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT04165837 on ClinicalTrials.gov