Status:
COMPLETED
First-in-human Study of MRT-6160 in Healthy Subjects
Lead Sponsor:
Monte Rosa Therapeutics, Inc
Conditions:
Healthy Volunteers
Eligibility:
All Genders
19-65 years
Phase:
PHASE1
Brief 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 pha...
Detailed Description
Detailed Description: The purpose of this study is to: Learn about the safety and tolerability of single and multiple ascending oral doses of MRT-6160 in healthy adult subjects
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2025
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT06597799
Start Date
August 7 2024
End Date
April 10 2025
Last Update
July 28 2025
Active Locations (2)
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1
Celerion, Inc.
Tempe, Arizona, United States, 85283
2
Celerion
Lincoln, Nebraska, United States, 68502