A Phase 1 Study to Evaluate the Safety of an Oral Biologic in Healthy Participants - Trial NCT06363383
Access comprehensive clinical trial information for NCT06363383 through Pure Global AI's free database. This Phase 1 trial is sponsored by Mage Biologics and is currently Recruiting. The study focuses on Ulcerative Colitis. Target enrollment is 48 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.
Study Focus
Sponsor & Location
Mage Biologics
Timeline & Enrollment
Phase 1
May 09, 2024
May 01, 2025
Primary Outcome
Incidence and severity of adverse events (AEs),Clinically significant changes from baseline in vital signs,Clinically significant changes from baseline in physical examination findings,Clinically significant changes from baseline in clinical laboratory assessments,Clinically significant changes from baseline in ECG parameters
Summary
The goal of this clinical trial is to learn if the oral biologic MB-001 is safe in healthy
 volunteers. The main questions it aims to answer are:
 
 Is the drug safe when administered orally at increasing doses? Researchers will compare the
 drug with placebo to see if there are more side effects in those receiving the drug.
 
 Participants will receive a single or five daily doses of the drug or placebo and will be
 asked to stay in the clinic for five days following the last dose.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06363383
Non-Device Trial