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

NCT ID: NCT07219368

Last Updated: 2025-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-08

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy Volunteer

Keywords

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MT-201 Phase 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
Double-Blind

Study Groups

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Multiple Ascending Dose Placebo

To assess the safety and tolerability of multiple intravenous/subcutaneous doses of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Single Ascending Dose of MT-201

To assess the safety and tolerability of single intravenous/subcutaneous doses of MT-201

Group Type EXPERIMENTAL

MT-201

Intervention Type DRUG

MT-201

Multiple Ascending Dose of MT-201

To assess the safety and tolerability of multiple intravenous/subcutaneous doses of MT-201

Group Type EXPERIMENTAL

MT-201

Intervention Type DRUG

MT-201

Single Ascending Dose Placebo Arm

To assess the safety and tolerability of single intravenous/subcutaneous doses of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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MT-201

MT-201

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mirador Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mirador Clinical Department, San Diego, California 92121

San Diego, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Toll-Free Number

Role: CONTACT

Phone: 844-206-4980

Email: [email protected]

Facility Contacts

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Mirador Clinical Department

Role: primary

Toll-Free Number

Role: backup

Other Identifiers

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MT-201-101

Identifier Type: -

Identifier Source: org_study_id