A First-in-Human Single and Multiple Ascending Dose Study of MT-701

NCT07396909 | Completed Phase 1 FDA Drug

• 1 other identifier: MT-701-101
• Study Type: interventional
• Target: 46
• 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-701 in healthy participants.

Conditions

Healthy Volunteers

Keywords

MT-701; Phase 1

Outcome Measures

Primary Outcomes (1)

• Number of Subjects with non-SAEs and SAES

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

  Up to 14 days post dose

Study Arms (2)

Part 1- Single Ascending Dose

EXPERIMENTAL

To assess the safety and tolerability of single intravenous/subcutaneous dose of MT-701.

Drug: MT-701

Part 2- Multiple Ascending Dose

EXPERIMENTAL

To assess the safety and tolerability of multiple intravenous/subcutaneous doses of MT-701.

Drug: MT-701

Interventions

MT-701 DRUG

MT-701

Part 1- Single Ascending Dose; Part 2- Multiple Ascending Dose

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 or female (of non-childbearing potential only) participants 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 must use highly effective forms of contraception during sexual intercourse with female partners of childbearing potential. A non-vasectomized, male subject must agree to use a condom with a chemical barrier method.
• 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 of any prescription drug within 21 days of study drug administration; or over-the-counter drug within 7 days of study drug administration.
• Administration or use of any investigational drug or device within 30 days preceding the first does of study drug administration.
• Blood donation within 60 days prior to dosing or plasma donation within 14 days prior to dosing.
• Sensitivity to any of the study drugs, or components thereof, or drug or other allergy that in the opinion of the Investigator or Sponsor Medical Monitor, contraindicates participation in the study.

Sponsors & Collaborators

• Mirador Therapeutics, Inc.: lead

Study Sites (1)

Mirador Clinical Department

San Diego, California, 92121, United States

Location

Study Design

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

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: January 12, 2026
• Primary Completion: April 16, 2026
• Study Completion: April 16, 2026
• Last Updated: May 26, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)