drugset / Trial / NCT07289776
A First-in-human Trial of GRT7041 in Healthy Participants
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GRT7041 | Unknown | — | — |
| Subject | Midazolam | Small molecule | — | — |
Indications
No indication recorded.