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

NCT07219368 | Recruiting Phase 1 FDA Drug

• 1 other identifier: MT-201-101
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 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.

Conditions

Healthy Volunteer

Keywords

MT-201; Phase 1

Outcome Measures

Primary Outcomes (1)

• Number of Participants with non-SAEs and SAES

  Incidence of adverse events, clinically significant laboratory abnormalities, clinically significant electrocardiogram, vital signs, and physical examination abnormalities.

  Up to 40 weeks

Study Arms (4)

Single Ascending Dose of MT-201

EXPERIMENTAL

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

Drug: MT-201

Multiple Ascending Dose of MT-201

EXPERIMENTAL

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

Drug: MT-201

Single Ascending Dose Placebo Arm

PLACEBO COMPARATOR

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

Drug: Placebo

Multiple Ascending Dose Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

MT-201 DRUG

MT-201

Multiple Ascending Dose of MT-201; Single Ascending Dose of MT-201

Placebo DRUG

Placebo

Multiple Ascending Dose Placebo; Single Ascending Dose Placebo Arm

Eligibility Criteria

• Age: 19 Years - 55 Years
• Gender Eligibility Details: male and female (of non-childbearing potential only)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mirador Therapeutics, Inc.: lead

Study Sites (1)

Mirador Clinical Department, San Diego, California 92121

San Diego, California, 92121, United States

RECRUITING

MeSH Terms

Interventions

adecatumumab

Central Study Contacts

Toll-Free Number

CONTACT

844-206-4980; clinicaltrials@miradortx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-Blind
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2025
• First Posted: October 21, 2025
• Study Start: October 8, 2025
• Primary Completion (Estimated): November 24, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)