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NCT06597799 · ClinicalTrials.gov registry record · Phase 1
First-in-human Study of MRT-6160 in Healthy Subjects
A Phase 1 study, sponsored by Monte Rosa Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 108
- Enrollment target
NCT06597799: Completed Phase 1 study, sponsored by Monte Rosa Therapeutics.
NCT06597799 is a Phase 1 study that has completed, run by Monte Rosa Therapeutics. The registered enrollment target is 108 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06597799, a Phase 1 study, has completed, sponsored by Monte Rosa Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 108 participants
- Enrollment target
Study Summary
The principal aim of this study is to obtain safety and tolerability data when MRT-6160 is administered orally as single and multiple doses to healthy subjects. This information, together with the pharmacokinetic (PK) data, will help establish the doses and dosing regimen suitable for future studies in patients. The study drug, MRT-6160, is experimental. This is the first study in which MRT-6160 will be given to humans. Part 1: Subjects will receive a single oral dose of MRT-6160 or placebo on Day 1 Part 2: Subjects will receive multiple oral doses of MRT-6160 or placebo for 7 consecutive days
Primary Outcome
Frequency of adverse events as assessed by the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 5.0
Interventions
- DRUG Placebo
- DRUG MRT-6160
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2024-08-07 |
| Est. Completion | 2025-04-10 |
| Phase | Phase 1 |
What the finished NCT06597799 record still lists
NCT06597799 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06597799 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06597799 about?
NCT06597799 is a clinical study titled "First-in-human Study of MRT-6160 in Healthy Subjects". The principal aim of this study is to obtain safety and tolerability data when MRT-6160 is administered orally as single and multiple doses to healthy subjects. This information, together with the pharmacokinetic (PK) data, will help establish the doses and dosing regimen suitable for future studies...
What is the current status of trial NCT06597799?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 108 participants. The study started on 2024-08-07. Estimated completion is 2025-04-10.
What interventions are being tested in trial NCT06597799?
The interventions under investigation include: Placebo (DRUG), MRT-6160 (DRUG).
Who is sponsoring clinical trial NCT06597799?
This trial is sponsored by Monte Rosa Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06597799's enrollment target sits among peer trials
108 523rd of 2000 higher than 1,470 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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