Trials / Completed

CompletedNCT04924114

A Study of MK-6194 (PT101) in Participants With Active Ulcerative Colitis (UC) (MK-6194-002)

A Phase 1b, Randomized, Adaptive, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of PT101 in Subjects With Active Ulcerative Colitis

Status: Completed
Phase: Phase 1
Study type: Interventional
Enrollment: 57 (actual)

Sponsor: Merck Sharp & Dohme LLC · Industry
Sex: All
Age: 18 Years – 80 Years
Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of MK-6194 in participants with active UC.

Conditions

Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	MK-6194	Subcutaneous injection
DRUG	MK-6194-matching placebo	Subcutaneous injection

Timeline

Start date: 2021-10-14
Primary completion: 2024-01-08
Completion: 2024-07-15
First posted: 2021-06-11
Last updated: 2025-08-29
Results posted: 2025-03-24

Locations

17 sites across 8 countries: United States, Georgia, Germany, Hungary, Moldova, Poland, Ukraine, United Kingdom

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04924114. Inclusion in this directory is not an endorsement.