drugset / Trial / NCT06363383
A Phase 1 Study to Evaluate the Safety of an Oral Biologic in Healthy Participants
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2024-05-09
- Primary completion
- 2025-07-04
- Completion
- 2025-07-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MB-001 | Protein / enzyme biologic | — | Oral |