drugset / Trial / NCT04224857
SAD/MAD Study in Healthy Subjects and Adults With UC to Evaluate Safety, Tolerability, PK, PD of AMT-101
RandomizedParallel-groupDouble-blindTreatment
Summary
A randomized, double-blind placebo-controlled first in human study in approximately 36 male healthy subjects and approximately 20 male and female patients with active UC who have had an inadequate response to or demonstrated intolerance to 5-ASA.
Timeline
- Start
- 2019-04-01
- Primary completion
- 2020-04-30
- Completion
- 2020-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VIMEKOFUSP | Protein / enzyme biologic | — | Oral |