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Taking people in GermanyPhase 1

Testing GRT-001 safety in healthy people and people with ulcerative colitis

Tests the safety and tolerability of GRT-001 in adults with ulcerative colitis and healthy volunteers.

Key facts

Who runs it
Granite Bio AG
Where
Berlin, GermanySee the site
Trial code
Registry title
A randomized, double-blind, placebo-controlled, single and multiple-dose-escalation, phase 1 study in healthy volunteers and patients with ulcerative colitis to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of GRT-001 (MONOlith trial)
Status
Recruiting
Phase
Phase 1
People taking part
112 people, planned
Started
9 Feb 2024
Expected to end
31 Dec 2026
Type of study
Interventional
Record updated
14 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for healthy volunteers and for adults with ulcerative colitis to test the safety and effects of GRT-001 compared with a placebo.

Age
18 years or older
Sex
All sexes can join

Where in Germany

  • Charite Research Organisation GmbHBerlin, GermanyTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Plain-language title
Testing GRT-001 safety in healthy people and people with ulcerative colitisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
14 July 2026