Testing MRT-6160 in healthy volunteers
Phase 1, First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Ascending Dose, and Food-Effect Study to Assess Safety, Tolerability, PK and PD of MRT-6160 in Healthy Subjects
PHASE1 · Monte Rosa Therapeutics, Inc · NCT06597799
This study is testing a new drug called MRT-6160 in healthy adults to see if it's safe and how well their bodies handle it.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 19 Years to 65 Years |
| Sex | All |
| Sponsor | Monte Rosa Therapeutics, Inc (industry) |
| Locations | 1 site (Lincoln, Nebraska) |
| Trial ID | NCT06597799 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and tolerability of the experimental drug MRT-6160 when administered orally to healthy adult subjects. Participants will receive either a single dose or multiple doses of MRT-6160 or a placebo over a specified period. The study will gather pharmacokinetic data to inform future dosing regimens for subsequent studies in patients. This is the first time MRT-6160 will be given to humans, making it a crucial step in its development.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 19-65 who do not smoke and can comply with the study protocol.
Not a fit: Patients with significant medical or psychiatric conditions or those who have recently undergone surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could pave the way for future treatments using MRT-6160 in patients.
How similar studies have performed: While this is a first-in-human study for MRT-6160, similar studies of new drugs have often shown success in establishing safety and tolerability.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy, adult, male or females 19-65 years of age * Non smoker who has not used nicotine and tobacco containing products for at least 3 months prior to start of study * Able to swallow oral medications * Understands the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol Exclusion Criteria: * History or presence of clinically significant medical or psychiatric condition or disease that will interfere with adherence to study protocol * Underwent surgical intervention or an operation within 4 weeks prior to start of study * Has active TB, latent TB, a history of TB, or had close contact with a person with active TB within 8 weeks prior to the first dosing * Female subject with a positive pregnancy test or who is lactating * Positive urine drug or alcohol screen results * Positive COVID-19 results indicating recent or current COVID-19 * Positive results for human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus or history of resolved hepatitis * Participation in another clinical study within 30 days or within 5 half-lives (if known) prior to start of study
Where this trial is running
Lincoln, Nebraska
- Celerion — Lincoln, Nebraska, United States (RECRUITING)
Study contacts
- Principal investigator: CRO — Celerion
- Study coordinator: Sponsor
- Email: Clinicaltrials@monterosatx.com
- Phone: 617-949-2643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Healthy Volunteers, MRT-6160, MRT-6160-001, MRT, Monte Rosa Therapeutics, Single Ascending Dose, Multiple Ascending Dose, SAD