Evaluation of MTX-463 Administered Subcutaneously in Healthy Adult Males

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Adult Male

In brief

A randomized, double-blind, placebo-controlled, study to assess the safety, tolerability, and PK of MTX-463 when administered via SC injection in healthy adult males.

Key facts

Study ID

NCT07450521

Run by

Mediar Therapeutics

People needed

8

Starts

2026-02-18

Expected to finish

2026-03-11

Last updated by the study team

2026-03-30

Who can join

Age: 18 and older, up to 60. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Males aged 18 to 60 years, inclusive
• Able to understand the study and provide signed, written informed consent
• Able to read and understand the language of the informed consent form and other study-related materials
• Willing and able to complete all protocol-required study visits and procedures
• Male participants with female partners of childbearing potential must use condoms during the treatment and until 125 days after the dose of study drug.

You may not qualify if…

• Any history of clinically significant lung disease as determined by the Investigator
• Any other concurrent active medical condition determined clinically significant by the Investigator
• Any current skin conditions or rashes that involve the planned area of injection
• Body mass index (BMI) >30 kg/m2
• Use of any systemic immunosuppressant medications, medications to treat diabetes, antipsychotics, anticoagulants, or other medications within 90 days of Screening
• Cancer or a history of cancer or lymphoproliferative disorder within 5 years of Screening
• Current infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
• Planning to contribute to pregnancy during the study and up to 125 days after the participant's dose of study drug
• History of severe depression, psychosis, or suicidal ideation, as determined by the Investigator, within 5 years of Screening
• Any clinically significant disease or laboratory abnormality detected at Screening that might interfere with a participant's ability to complete the study, on-study evaluations, or participant safety
• Known allergy to MTX-463 or any of its excipients, or a history of a prior allergic reaction to a monoclonal antibody therapeutic

Where it is running

• Icon Slc Cru — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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