NCT06363383

A Phase 1 Study to Evaluate the Safety of an Oral Biologic in Healthy Participants

A Double-blind Placebo-controlled Phase 1 Study to Evaluate the Safety and Efficacy of MB-001 in Single and Multiple Ascending Doses in Healthy Human Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Mage Biologics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a two-stage, single-center, double-blinded, randomized, placebo-controlled study evaluating the safety ofMB-001 in healthy adult participants. The two stages are: * A single ascending dose (SAD) stage in healthy participants. * A multiple ascending dose (MAD) stage in healthy participants. Up to 5 cohorts of healthy adult participants will receive a single oral dose of either MB-001 or placebo. Following a review of all safety data available for the current cohort and any preceding cohorts, the Safety Review Committee (SRC) will decide whether to proceed to the next cohort. The MAD stage in healthy participants will commence once sufficient safety data are available from the SAD stage, after the completion of all SAD cohorts.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
BIOLOGICAL	MB-001	Oral, delayed release formulation of a biologic drug

Timeline

• Start date: 2024-05-09
• Primary completion: 2025-07-04
• Completion: 2025-07-04
• First posted: 2024-04-12
• Last updated: 2025-09-30

Locations

1 site across 1 country: Australia