Evaluation of MTX-463 Administered Subcutaneously in Healthy Adult Males
MTX-463-I102: A Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of MTX-463 Administered Subcutaneously in Healthy Adult Males
1 other identifier
interventional
8
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2026
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2026
CompletedStudy Start
First participant enrolled
February 18, 2026
CompletedFirst Posted
Study publicly available on registry
March 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 11, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2026
CompletedMarch 30, 2026
March 1, 2026
21 days
February 10, 2026
March 25, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
PK will be evaluated by area under the plasma concentration versus time curve from time zero to t (AUC0-t) of MTX-463
Unit of Measure: Nanogram·hour per milliliter (ng·h/mL)
22 Days
PK will be evaluated by Maximum Observed Plasma Concentration (Cmax) of MTX-463
Unit of measure: ng/mL
22 Days
Comparisons of Maximum Observed Plasma Concentration (Cmax) of MTX-463 will be made to historical single-dose 4-mg/kg IV data.
Unit of measure: ng/mL
22 Days
Comparisons of area under the plasma concentration versus time curve from time zero to t (AUC0-t) of MTX-463 will be made to historical single-dose 4-mg/kg IV data.
Unit of Measure: Nanogram·hour per milliliter (ng·h/mL)
22 Days
Secondary Outcomes (7)
Incidence of serious adverse events (SAEs)
22 days
Incidence of Treatment Emergent Adverse Events (TEAEs)
22 days
Incidence of Treatment Related Adverse Events (TRAEs)
22 days
Clinically significant findings on clinical laboratory tests
22 days
Descriptive statistics on vital signs.
22 Days
- +2 more secondary outcomes
Other Outcomes (5)
Incidence of injection site pain and injection site reactions
22 days
Presence of Anti-Drug Antibodies (ADA)
22 days
Signal inhibition in the confirmatory assay of Anti-Drug Antibodies (ADA)
22 days
- +2 more other outcomes
Study Arms (2)
MTX-463
EXPERIMENTALMTX-463
Placebo
PLACEBO COMPARATORPlacebo
Interventions
MTX-463 is an immunoglobin G1 (IgG1) monoclonal antibody directed against WNT-inducible signaling pathway protein 1 (WISP1). WISP1 (aka CCN-4) is a matricellular protein that appears to be upregulated locally in response to certain chronic diseases, including IPF, and malignancies.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Icon Slc Cru
Salt Lake City, Utah, 84124, United States
Study Officials
- STUDY CHAIR
Todd Astor, MD
Mediar Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2026
First Posted
March 4, 2026
Study Start
February 18, 2026
Primary Completion
March 11, 2026
Study Completion
March 11, 2026
Last Updated
March 30, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share