COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-08-07
Study Completion:2025-04-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06597799

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy, adult, male or females 19-65 years of age
  2. * Non smoker who has not used nicotine and tobacco containing products for at least 3 months prior to start of study
  3. * Able to swallow oral medications
  4. * Understands the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol
  1. * History or presence of clinically significant medical or psychiatric condition or disease that will interfere with adherence to study protocol
  2. * Underwent surgical intervention or an operation within 4 weeks prior to start of study
  3. * 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
  4. * Female subject with a positive pregnancy test or who is lactating
  5. * Positive urine drug or alcohol screen results
  6. * Positive COVID-19 results indicating recent or current COVID-19
  7. * Positive results for human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus or history of resolved hepatitis
  8. * Participation in another clinical study within 30 days or within 5 half-lives (if known) prior to start of study

Contacts and Locations

Principal Investigator

CRO
PRINCIPAL_INVESTIGATOR
Celerion

Study Locations (Sites)

Celerion, Inc.
Tempe, Arizona, 85283
United States
Celerion
Lincoln, Nebraska, 68502
United States

Collaborators and Investigators

Sponsor: Monte Rosa Therapeutics, Inc

  • CRO, PRINCIPAL_INVESTIGATOR, Celerion

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-07
Study Completion Date2025-04-10

Study Record Updates

Study Start Date2024-08-07
Study Completion Date2025-04-10

Terms related to this study

Keywords Provided by Researchers

  • MRT-6160
  • MRT-6160-001
  • MRT
  • Monte Rosa Therapeutics
  • Healthy Volunteers
  • Single Ascending Dose
  • Multiple Ascending Dose
  • SAD
  • MAD

Additional Relevant MeSH Terms

  • Healthy Volunteers