MTX-463-I101: A Phase 1 Randomized, Double-Blind, Dose-Escalating Study to Assess the Safety, Tolerability, and Pharmacokinetics of MTX-463 in Healthy Adults

MTX-463-I101

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-463 administered in healthy adults.

2024-04-15

2024-11-16

2024-11-16

Recruiting

Early phase I

56

Key Inclusion Criteria: * All genders, ages 18 to 60 years, inclusive * Willing and able to complete all protocol-required study visits and procedures * Non-smoker and has not used nicotine- or cotinine-containing products (including tobacco, nicotine gum, patches, and e-cigarettes) for at least 90 days before Screening and until the last study visit * Willing to refrain from marijuana- or cannabinol-containing products for 90 days before Screening and until the last study visit * Willing to refrain from ingestion of alcohol from 7 days before Screening 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 28 days after the last dose of study drug Key Exclusion Criteria: * - Any history of clinically significant lung disease as determined by the Investigator, including but not limited to asthma, chronic obstructive pulmonary disease, pulmonary fibrosis, pulmonary embolus, or pulmonary arterial hypertension * Any other concurrent active medical condition determined clinically significant by the Investigator * Body mass index (BMI) \>40 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 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 28 days 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 substance use disorder as specified in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, within 1 year 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 * 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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2024-05-06