drugset / Trial / NCT07289776

A First-in-human Trial of GRT7041 in Healthy Participants

NCT07289776 ↗

Phase 1 Recruiting 70 enrolled Grünenthal GmbH
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this trial is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GRT7041 in healthy male and female (Women of non-childbearing potential) participants. The trial duration will be up to approximately 6 weeks for participants in Part 1 (Single ascending dose \[SAD\]), except for participants taking part in the food effect cohort SAD3 where the trial duration will be up to approximately 8 weeks. The trial duration will be up to approximately 7 weeks in Part 2 (Multiple ascending dose \[MAD\]), and the Treatment Period will be up to 14 days (for Part 2). The trial will include a Screening Visit, an in-house stay period and Follow-up (FU) Visit/End-of-Trial (EoT) Visit.

Timeline

Start
2026-01-14
Primary completion
2026-08-24
Completion
2026-08-28

Drugs

EvaluationDrugModalityDoseRoute
Subject GRT7041 Unknown — —
Subject Midazolam Small molecule — —

Indications

No indication recorded.