A First-in-Human Safety Trial of MTX-474

Launched by MEDIAR THERAPEUTICS · Jul 30, 2024

Keywords

ClinConnect Summary

This clinical trial, called a First-in-Human Safety Trial of MTX-474, is studying a new drug to see how safe it is for healthy adults. The goal is to understand how the drug works in the body and if it can be tolerated well when given in different doses. The trial is currently looking for participants aged 18 to 60 who are generally healthy and can commit to all the required study visits and procedures. If you are a non-smoker or smoke very little, and you can avoid nicotine and marijuana products before and during the study, you may be eligible to take part.

Participants in this trial will receive either the study drug or a placebo (a harmless substitute) in a controlled setting. They will be monitored closely to ensure their safety throughout the study. It's important to note that there are specific health conditions and medications that would prevent someone from joining, so potential participants should discuss their health history with the study team. Overall, this research aims to gather important information about MTX-474 and its effects before it can be considered for wider use.

Gender

ALL

Eligibility criteria

• 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.
• 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.