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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

Titles & IDs
Public title
A First-in-Human Safety Trial of MTX-474
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
Secondary ID [1] 0 0
MTX-474-S101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Treatment-Related Adverse Events in healthy volunteers
Timepoint [1] 0 0
Through Day 29 (SAD Cohort) or Day 50 (MAD Cohort)
Primary outcome [2] 0 0
MTX-474 PK by dose will be evaluated for Cmax, as feasible
Timepoint [2] 0 0
Through Day 29 (SAD Cohort) or Day 50 (MAD Cohort)
Primary outcome [3] 0 0
Serum sample results will be summarized for presence of Anti-Drug Antibodies during the SAD and MAD portions of the study
Timepoint [3] 0 0
Through Day 29 (SAD Cohort) or Day 50 (MAD Cohort)
Primary outcome [4] 0 0
MTX-474 PK by dose will be evaluated for AUC0-t, as feasible
Timepoint [4] 0 0
Through Day 29 (SAD Cohort) or Day 50 (MAD Cohort)
Primary outcome [5] 0 0
MTX-474 PK by dose will be evaluated for AUC0-tau (MAD only), as feasible
Timepoint [5] 0 0
Through Day 29 (SAD Cohort) or Day 50 (MAD Cohort)
Primary outcome [6] 0 0
MTX-474 PK by dose will be evaluated for AUC0-8, as feasible
Timepoint [6] 0 0
Through Day 29 (SAD Cohort) or Day 50 (MAD Cohort)
Secondary outcome [1] 0 0
Blood serum samples will be collected to assess the target engagement of MTX-474 in healthy adult participants
Timepoint [1] 0 0
Through Day 29 (SAD Cohort) or Day 50 (MAD Cohort)

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.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/05/2025
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Nucleus Network - Herston
Recruitment postcode(s) [1] 0 0
4006 - Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Mediar Therapeutics
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
ProPharma Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jeffrey Bornstein, MD
Address 0 0
Mediar Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jeffrey Bornstein, MD
Address 0 0
Country 0 0
Phone 0 0
617-620-3403
Fax 0 0
Email 0 0
jeffrey@mediartx.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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