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RecruitingNCT07219368Updated Nov 4, 2025

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

A Phase 1 interventional study of MT-201 and Placebo in Healthy Volunteer, sponsored by Mirador Therapeutics, Inc.. Recruiting at 1 site in United States. Open to participants aged 19 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-04.

Sponsored by Mirador Therapeutics, Inc. · Phase 1, Interventional, and Other

From the registry’s dates

  • Started Oct 2025; still recruiting 11 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
19 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteer

Keywords

  • MT-201
  • Phase 1
03

In context

Lead sponsor

Mirador Therapeutics, Inc. is the lead sponsor of 6 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 55 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
72 participants (estimated)

Study arms

  • Experimental
    Single Ascending Dose of MT-201

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

    Drug: MT-201

  • Experimental
    Multiple Ascending Dose of MT-201

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

    Drug: MT-201

  • Placebo comparator
    Single Ascending Dose Placebo Arm

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

    Drug: Placebo

  • Placebo comparator
    Multiple Ascending Dose Placebo

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

    Drug: Placebo

Interventions

  • DrugMT-201

    MT-201

  • DrugPlacebo

    Placebo

06

What researchers measure

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.

    Time frame: Up to 40 weeks

07

Study locations

1 of 1 sites recruiting
  • Mirador Clinical Department, San Diego, California 92121
    San Diego, California 92121, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07219368
Lead sponsor
Mirador Therapeutics, Inc.
Responsible party
Sponsor
First posted
Oct 21, 2025
Start date
Oct 8, 2025
Primary completion
Nov 24, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Nov 4, 2025

Study contacts

Toll-Free Number
Contact
clinicaltrials@miradortx.com
844-206-4980

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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