drugset / Trial / NCT04224857

SAD/MAD Study in Healthy Subjects and Adults With UC to Evaluate Safety, Tolerability, PK, PD of AMT-101

NCT04224857

Phase 1 Completed 52 enrolled Applied Molecular Transport
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

EvaluationDrugModalityDoseRoute
Subject VIMEKOFUSP Protein / enzyme biologic Oral

Indications