Status:
COMPLETED
A First-in-Human Safety Trial of MTX-474
Lead Sponsor:
Mediar Therapeutics
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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...
Detailed Description
This is 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2025
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT06535841
Start Date
July 10 2024
End Date
April 24 2025
Last Update
May 18 2025
Active Locations (1)
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1
Nucleus Network
Herston, Queensland, Australia, 4006