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

NCT04224857 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2020-10-28

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Applied Molecular Transport

    lead INDUSTRY

Principal Investigators

  • Bittoo Kanwar, MD · Applied Molecular Transport

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2020-04-30
Completion
2020-04-30

Countries

  • Georgia
  • Germany
  • Moldova
  • Ukraine

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 NCT04224857 on ClinicalTrials.gov