MedTrace Logo

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

NCT06363383 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-09-30

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

MB-001

Oral, delayed release formulation of a biologic drug

Sponsors & Collaborators

  • Alimentiv Inc.

    collaborator OTHER

  • Mage Biologics

    lead INDUSTRY

Principal Investigators

  • Johannes Spleiss · Mage Biologics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-09
Primary Completion
2025-07-04
Completion
2025-07-04

Countries

  • Australia

Study Locations

More Related Trials

Entities

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 NCT06363383 on ClinicalTrials.gov