NCT07423299

Brief Summary

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Doses of MT-251 in Healthy Participants

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
8mo left

Started Jan 2026

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Jan 2026Mar 2027

Study Start

First participant enrolled

January 23, 2026

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2027

Last Updated

February 25, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

February 13, 2026

Last Update Submit

February 23, 2026

Conditions

Healthy Volunteers

Keywords

MT-251Phase 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-251.

Drug: MT-251

Part 2- Multiple Ascending Dose

EXPERIMENTAL

To assess the safety and tolerability of multiple intravenous/subcutaneous doses of MT-251.

Drug: MT-251

Interventions

MT-251DRUG

MT-251

Part 1- Single Ascending DosePart 2- Multiple Ascending Dose

Eligibility Criteria

Age19 Years - 55 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMale and female (of non-childbearing potential only).
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female 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 subjects 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.
  • Continuous non-smoker who has not used tobacco or nicotine-containing products for at least 3 months prior to the first dose of drug.
  • 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 or 5 half-lives (whichever is longer) of study drug administration; or over-the-counter drug within 7 days or 5 half-lives (whichever is longer) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mirador Clinical Department

San Diego, California, 92121, United States

RECRUITING

Central Study Contacts

Toll-Free Number

CONTACT

844-206-4980clinicaltrials@miradortx.com

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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2026

First Posted

February 20, 2026

Study Start

January 23, 2026

Primary Completion (Estimated)

March 8, 2027

Study Completion (Estimated)

March 8, 2027

Last Updated

February 25, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)