Clinical trial NCT06597799: First-in-human Study of MRT-6160 in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: MRT-6160
MRT-6160-001
MRT
Monte Rosa Therapeutics
Healthy Volunteers
Single Ascending Dose
Multiple Ascending Dose
SAD
MAD
Lead sponsor: Monte Rosa Therapeutics, Inc
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 76
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential Ascending Doses, Multiple Ascending Doses
Primary purpose: TREATMENT

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 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

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 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

Primary outcomes:
measure: To evaluate the safety and tolerability of single ascending doses of MRT-6160 in healthy adult subjects
timeFrame: 6 weeks
measure: To evaluate the safety and tolerability of multiple ascending doses of MRT-6160 in healthy adult subjects
timeFrame: 7.5 weeks
Secondary outcomes:
measure: To evaluate the effects of single dose or multiple doses of MRT-6160 on the heart rate (HR)-corrected QT (QTc) interval by assessing the concentration QT (C-QT) relationship using exposure-response modelling in healthy adult subjects.
timeFrame: 6 - 8 weeks
measure: To characterize the PK profile of MRT-6160 in plasma after single or multiple doses of MRT-6160 in healthy adult subjects, with and without high fat/high calorie meal
timeFrame: 6 - 8 weeks
measure: To characterize the PK profile of MRT-6160 in plasma after single or multiple doses of MRT-6160 in healthy adult subjects, with and without high fat/high calorie meal
timeFrame: 6 - 8 weeks
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
affiliation: Celerion
name: CRO
role: PRINCIPAL_INVESTIGATOR
References: