NCT04224857

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

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose in Healthy Subjects and Multiple-Ascending Dose in Adult Patients With Ulcerative Colitis Study to Evaluate the Safety, Tolerability, PK and PD of Oral AMT-101

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Applied Molecular Transport · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. Subjects may but are not required to have been exposed to corticosteroids, or immunosuppressive agents. In case the subject has been exposed to any of these treatments, he/she must have had either an inadequate response, failed response or demonstrated intolerance. Patients may be 1. naïve to anti-TNFα therapy or 2. have failed or demonstrated intolerance to anti-TNF-α therapy.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	AMT-101	Single or daily dosing at doses A, B, C, D, E, F
DRUG	Placebos	Single or daily dosing at doses A, B, C, D, E, F

Timeline

• Start date: 2019-04-01
• Primary completion: 2020-04-30
• Completion: 2020-04-30
• First posted: 2020-01-13
• Last updated: 2020-10-28

Locations

4 sites across 4 countries: Georgia, Germany, Moldova, Ukraine