First-in-human Study of MRT-6160 in Healthy Subjects

Launched by MONTE ROSA THERAPEUTICS, INC · Sep 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying an experimental drug called MRT-6160 to learn how safe it is and how well it can be tolerated when taken by healthy adults. This is the first time MRT-6160 will be given to people, and the goal is to find out the best doses to use in future studies involving patients. The trial will involve two parts: in the first part, participants will take a single dose of MRT-6160 or a placebo (a pill with no active medication) on the first day. In the second part, participants will take multiple doses of MRT-6160 or a placebo for seven days in a row.

To be eligible for this study, participants must be healthy adults aged 19 to 65 who do not smoke and are able to swallow pills. They should also understand the study procedures and agree to follow the guidelines. People with certain medical conditions, recent surgeries, or those who are pregnant or breastfeeding cannot participate. The study is currently looking for volunteers, and participation will involve taking the study drug and attending follow-up appointments to monitor health and safety.

Gender

ALL

Eligibility 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