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Recruiting NCT07219368

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

Phase I Interventional Healthy Volunteer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MT-201, Placebo.
Who it may be relevant to
Registry conditions: Healthy Volunteer. Basic parameters: 19 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug MT-201
    MT-201
  • Drug Placebo
    Placebo

Primary outcome measures

  • Number of Participants with non-SAEs and SAES [Time frame: Up to 40 weeks]

Eligibility criteria

Inclusion criteria

  • Male participant or female participant of nonchildbearing potential between 19 and 55 years of age (inclusive) at the time of signing informed consent.
  • 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.
  • 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.
  • Good general health.
  • Able to provide written informed consent and understand and comply with the requirements of the study.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Single group
Masking
Double blind
Primary purpose
Other

Study locations

United States · 1 center
  • Mirador Clinical Department, San Diego, California 92121 — San Diego

Identifiers

NCT: NCT07219368 · MT-201-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗