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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06535841
Registration number
NCT06535841
Ethics application status
Date submitted
30/07/2024
Date registered
2/08/2024
Date last updated
18/05/2025
Titles & IDs
Public title
A First-in-Human Safety Trial of MTX-474
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Scientific title
MTX-474-S101: A Phase 1 Randomized, Double-Blind, Dose-Escalating Study to Assess the Safety, Tolerability, and Pharmacokinetics of MTX-474 in Healthy Adults
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Secondary ID [1]
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MTX-474-S101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - MTX-474
Other interventions - Placebo
Experimental: MTX-474 - Biological: MTX-474
Placebo comparator: Placebo - Placebo
Treatment: Other: MTX-474
MTX-474 is an immunoglobin G1 (IgG1) monoclonal antibody directed against Ephrin B2 that binds to and has demonstrated ability to block phosphorylation of its preferred receptor EphB4. Increased levels of circulating soluble EphrinB2 have been found in patients with systemic sclerosis.
Other interventions: Placebo
Matching Placebo - Normal Saline
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of Treatment-Related Adverse Events in healthy volunteers
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Assessment method [1]
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Clinical Safety Labs are collected, and Adverse Events are assessed in both inpatient and outpatient clinic visits
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Timepoint [1]
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Through Day 29 (SAD Cohort) or Day 50 (MAD Cohort)
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Primary outcome [2]
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MTX-474 PK by dose will be evaluated for Cmax, as feasible
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Assessment method [2]
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Blood serum samples will be collected at protocol-specified timepoints throughout the study
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Timepoint [2]
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Through Day 29 (SAD Cohort) or Day 50 (MAD Cohort)
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Primary outcome [3]
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Serum sample results will be summarized for presence of Anti-Drug Antibodies during the SAD and MAD portions of the study
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Assessment method [3]
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Blood serum samples will be collected at protocol-specified timepoints throughout the study to assess for the presence and titer (if applicable) of Anti-Drug Antibodies.
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Timepoint [3]
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Through Day 29 (SAD Cohort) or Day 50 (MAD Cohort)
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Primary outcome [4]
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MTX-474 PK by dose will be evaluated for AUC0-t, as feasible
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Assessment method [4]
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Blood serum samples will be collected at protocol-specified timepoints throughout the study
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Timepoint [4]
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Through Day 29 (SAD Cohort) or Day 50 (MAD Cohort)
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Primary outcome [5]
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MTX-474 PK by dose will be evaluated for AUC0-tau (MAD only), as feasible
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Assessment method [5]
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Blood serum samples will be collected at protocol-specified timepoints throughout the study
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Timepoint [5]
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Through Day 29 (SAD Cohort) or Day 50 (MAD Cohort)
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Primary outcome [6]
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MTX-474 PK by dose will be evaluated for AUC0-8, as feasible
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Assessment method [6]
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Blood serum samples will be collected at protocol-specified timepoints throughout the study
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Timepoint [6]
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Through Day 29 (SAD Cohort) or Day 50 (MAD Cohort)
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Secondary outcome [1]
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Blood serum samples will be collected to assess the target engagement of MTX-474 in healthy adult participants
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Assessment method [1]
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These assessments will be summarized as: Change from Baseline in bound EphrinB2 levels Change from Baseline in free EphrinB2 levels Change from Baseline in the percent phorphoEphB4 (pEpB4) positive cells and ratio of pEpB4 to total EphB4 positive cells
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Timepoint [1]
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Through Day 29 (SAD Cohort) or Day 50 (MAD Cohort)
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Eligibility
Key inclusion criteria
* All genders, ages 18 to 60 years, inclusive
* Willing and able to complete all protocol-required study visits and procedures
* Consumption of not more than 5 cigarettes or other cotinine-containing products (including tobacco, nicotine gum, patches, and e-cigarettes) per week as long as they are willing to abstain nicotine use approximately 5 days prior to admission and during inpatient stays
* Willing to refrain from marijuana- or cannabinol-containing products for 30 days before Screening and until the last study visit
* Agree to a highly effective method of contraception for 28 days prior to the first dose of study drug, and persist through 65 days after the last dose of study drug.
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Any concurrent active medical condition determined clinically significant by the Investigator
* Body mass index (BMI) >32 kg/m2 or body weight >100kg
* 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 other than adequately treated non-melanomatous skin cancers or cervical carcinoma in situ
* Current infection with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) as evidenced by a positive hepatitis B surface antigen or a positive HIV test at Screening
* Currently pregnant, lactating, or planning to conceive or contribute to pregnancy during the trial and up to 65 days (for women of childbearing potential) or 125 days (for males) after the participant's last dose of study drug, if applicable
* History of severe depression, psychosis, or suicidal ideation within 5 years of Screening
* History of anaphylaxis or other significant allergies in the opinion of the Investigator
* History of substance use disorder as specified in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, within 1 year of Screening
* Positive screen for drugs of abuse or alcohol intake at Screening or admission to the CRU (Day -1)
* 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
* Any surgical procedure, including planned procedures within 12 weeks of Screening
* Participation in another research study of an investigational agent within 30 days of Screening or 5 half-lives of the agent, whichever is longer.
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/07/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
24/04/2025
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Sample size
Target
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Accrual to date
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Final
78
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Nucleus Network - Herston
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Recruitment postcode(s) [1]
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4006 - Herston
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Mediar Therapeutics
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
A randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study to assess the safety, tolerability, and PK of single and multiple ascending doses of MTX-474 administered in healthy adults.
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Trial website
https://clinicaltrials.gov/study/NCT06535841
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Jeffrey Bornstein, MD
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Address
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Mediar Therapeutics
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Jeffrey Bornstein, MD
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Address
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Country
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Phone
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617-620-3403
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06535841
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