Healthy Adult MalePhase 1NCT07450521
Evaluation of MTX-463 Administered Subcutaneously in Healthy Adult Males
A Phase 1 study testing MTX-463 in people with Healthy Adult Male, run by Mediar Therapeutics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male
- What is being tested?
- MTX-463
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2026to 11 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
This is 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. The study will consist of a single cohort comprising 8 healthy male participants, who on Day 1 will be randomly assigned to receive MTX-463 or matched placebo. Randomization will be in a 3:1 ratio such that 6 participants will receive MTX-463 and 2 will receive placebo. Participants randomized to MTX-463 will receive a dose of 250 mg of MTX-463.
Participants randomized to placebo will receive SC injections containing sodium chloride 0.9%. The injections will be given under the skin of the abdominal wall on Day 1. Blood will be drawn pre-dose on Day 1 for PK and antidrug antibodies (ADAs) and post-dose for PK at 6 and 24 hours. Participants will remain in the clinical research unit (CRU) for 24 hours after their injections, and then they will return for outpatient PK blood draws on Days 3 through 8, 15, and 22, with blood drawn for ADA assessment on Days 15 and 22. Each participant will undergo assessments at specified timepoints on Days 1 through 22 as detailed in Table 1. End-of-study procedures will be completed on Day 22 or upon early termination (ET). Local safety and tolerability at the injection site will be assessed at the time of the injections and for 24 hours afterward, and on Days 5, 8, 15 (±1 day), and 22 (±2 days) (EOS/ET).
- Conditions
- Healthy Adult Male
- Being tested
- MTX-463, Placebo
- Keywords
- MTX-463-I102, MTX-463, Healthy Volunteer, Healthy, Adult, Male, Monoclonal Antibody, MAB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTX-463Biological
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.
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| MTX-463 | Experimental | MTX-463 Receives: Biological: MTX-463 |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 22 Days
PK will be evaluated by Maximum Observed Plasma Concentration (Cmax) of MTX-463
Unit of measure: ng/mL
Measured: 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
Measured: 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)
Measured: 22 Days
Secondary outcomes (7)
Incidence of serious adverse events (SAEs)
Number SAEs as defined by protocol criteria
Measured: 22 days
Incidence of Treatment Emergent Adverse Events (TEAEs)
Number of TEAEs summarized by seriousness and maximum severity as defined by protocol criteria
Measured: 22 days
Incidence of Treatment Related Adverse Events (TRAEs)
Number of TRAEs summarized by seriousness and maximum severity as defined by Protocol criteria
Measured: 22 days
Clinically significant findings on clinical laboratory tests
Clinically significant findings in hematology, clinical chemistry, urinalysis, and other protocol-specified laboratory parameters will be summarized.
Units of Measure: Standard laboratory units (e.g., g/dL, mEq/L, mg/dL, increase by factor)
Measured: 22 days
Descriptive statistics on vital signs.
Descriptive statistics on temperature (Units: degrees Celcius), pulse rate (Units: beats per minute), respiratory rate (Units: breaths per minute), and blood pressure (Units: mmHg) will be assessed for change from Baseline, when applicable, and summarized by timepoint.
Measured: 22 Days
Descriptive statistics on electrocardiograms (ECGs)
Descriptive statistics on ECG parameters (including but not limited to PR interval, QRS interval, QT, QTcF, and RR) will be assessed for change from Baseline, when applicable, and summarized by timepoint.
Units: msec
Measured: 22 Days
Descriptive statistics on clinical laboratory tests.
Descriptive statistics on hematology, clinical chemistry, urinalysis, and other protocol-specified laboratory parameters will be assessed for change from Baseline, when applicable, and summarized by timepoint.
Units of Measure: Standard laboratory units (e.g., g/dL, mEq/L, mg/dL, increase by factor)
Measured: 22 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start18 Feb 2026
- Primary completion11 Mar 2026
- Study completion11 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mediar Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Todd Astor, MD, Study chair, Mediar Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450521
- Sponsor's protocol ID
- MTX-463-I102
- Status last verified
- Mar 2026
- First submitted
- 10 Feb 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07450521
- Acronym / sponsor ID
- MTX-463-I102
- Conditions
- Healthy Adult Male
- Keywords
- MTX-463-I102, MTX-463, Healthy Volunteer, Healthy, Adult, Male, Monoclonal Antibody, MAB
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Mediar TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- 11 Mar 2026 (actual)
- Study completion
- 11 Mar 2026 (actual)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is 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. The study will consist of a single cohort comprising 8 healthy male participants, who on Day 1 will be randomly assigned to receive MTX-463 or matched placebo. Randomization will be in a 3:1 ratio such that 6 participants will receive MTX-463 and 2 will receive placebo. Participants randomized to MTX-463 will receive a dose of 250 mg of MTX-463.
Participants randomized to placebo will receive SC injections containing sodium chloride 0.9%. The injections will be given under the skin of the abdominal wall on Day 1. Blood will be drawn pre-dose on Day 1 for PK and antidrug antibodies (ADAs) and post-dose for PK at 6 and 24 hours. Participants will remain in the clinical research unit (CRU) for 24 hours after their injections, and then they will return for outpatient PK blood draws on Days 3 through 8, 15, and 22, with blood drawn for ADA assessment on Days 15 and 22. Each participant will undergo assessments at specified timepoints on Days 1 through 22 as detailed in Table 1. End-of-study procedures will be completed on Day 22 or upon early termination (ET). Local safety and tolerability at the injection site will be assessed at the time of the injections and for 24 hours afterward, and on Days 5, 8, 15 (±1 day), and 22 (±2 days) (EOS/ET).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTX-463 | Experimental | Biological: MTX-463MTX-463 |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MTX-463MTX-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. | Biological | MTX-463 |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
PK will be evaluated by area under the plasma concentration versus time curve from time zero to t (AUC0-t) of MTX-463
Time frame: 22 Days
Unit of Measure: Nanogram·hour per milliliter (ng·h/mL)
PK will be evaluated by Maximum Observed Plasma Concentration (Cmax) of MTX-463
Time frame: 22 Days
Unit of measure: ng/mL
Comparisons of Maximum Observed Plasma Concentration (Cmax) of MTX-463 will be made to historical single-dose 4-mg/kg IV data.
Time frame: 22 Days
Unit of measure: ng/mL
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.
Time frame: 22 Days
Unit of Measure: Nanogram·hour per milliliter (ng·h/mL)
7 secondary outcomes
Incidence of serious adverse events (SAEs)
Time frame: 22 days
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: 22 days
Incidence of Treatment Related Adverse Events (TRAEs)
Time frame: 22 days
Clinically significant findings on clinical laboratory tests
Time frame: 22 days
Descriptive statistics on vital signs.
Time frame: 22 Days
Descriptive statistics on electrocardiograms (ECGs)
Time frame: 22 Days
Descriptive statistics on clinical laboratory tests.
Time frame: 22 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Astor, MD study chair
Mediar Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MTX-463 in people with Healthy Adult Male, run by Mediar Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK will be evaluated by area under the plasma concentration versus time curve from time zero to t (AUC0-t) of MTX-463 (time frame: 22 Days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.