A First-in-Human Single and Multiple Ascending Dose Study of MT-201

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Doses of MT-201 in Healthy Participants

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07219368

Enrollment

Registered

2025-10-21

Start date

2025-10-08

Completion date

2026-12-31

Last updated

2025-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

MT-201, Phase 1

Brief summary

First-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single and multiple doses of MT-201 in healthy participants.

Interventions

DRUGMT-201

MT-201

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Masking description

Double-Blind

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

1. Male participant or female participant of nonchildbearing potential between 19 and 55 years of age (inclusive) at the time of signing informed consent. 2. Female participants must be of nonchildbearing potential, defined as postmenopausal or surgically sterile, and have official documentation, at least 6 months prior to the first dose. 3. Male participants with female partners of childbearing potential who are involved in heterosexual intercourse or activities that could lead to pregnancy must use barrier method of contraception (male condom) and refrain from sperm donation. 4. Good general health. 5. Able to provide written informed consent and understand and comply with the requirements of the study.

Exclusion criteria

1. History or presence of any clinically significant organ system disease. 2. Abnormal laboratory assessments, physical exam of ECG outside the normal range that is judged by the Investigator to be clinically significant. 3. History of alcohol or drug abuse within the past 24 months. 4. Current use or history of regular tobacco, or nicotine-containing products within 3 months prior to screening. 5. Administration or use of any investigational drug or device within 30 days preceding the first dose of study drug administration. 6. Blood donation within 60 days prior to dosing or plasma donation within 14 days prior to dosing.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants with non-SAEs and SAES	Up to 40 weeks	Incidence of adverse events, clinically significant laboratory abnormalities, clinically significant electrocardiogram, vital signs, and physical examination abnormalities.

Countries

United States

Contacts

Primary ContactToll-Free Number

clinicaltrials@miradortx.com844-206-4980

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026