A First-in-Human Safety Trial of MTX-463

NCT06401213 | Completed Phase 1 FDA Drug

• 1 other identifier: MTX-463-I101
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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-463 administered in healthy adults.

Conditions

Healthy

Keywords

HEALTHY VOLUNTEER; SAD; MAD; MTX-463-I101; MTX-463; WISP-1; ADULT

Outcome Measures

Primary Outcomes (6)

• Incidence of Treatment-Related Adverse Events in healthy volunteers

  Clinical Safety Labs are collected, and Adverse Events are assessed in both inpatient and outpatient clinic visits

  Through Day 60 (SAD Cohort) or Day 82 (MAD Cohort)

• MTX-463 PK by dose will be evaluated for Cmax, as feasible

  Blood serum samples will be collected at protocol-specified timepoints throughout the study

  Through Day 60 (SAD Cohort) or Day 82 (MAD Cohort)

• Serum sample results will be summarized for presence of Anti-Drug Antibodies during the SAD and MAD portions of the study.

  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.

  Through Day 60 (SAD Cohort) or Day 82 (MAD Cohort)

• MTX-463 PK by dose will be evaluated for AUC0-t, as feasible.

  Blood serum samples will be collected at protocol-specified timepoints throughout the study

  Through Day 60 (SAD Cohort) or Day 82 (MAD Cohort)

• MTX-463 PK by dose will be evaluated for AUC0-tau (MAD only), as feasible

  Blood serum samples will be collected at protocol-specified timepoints throughout the study

  Through Day 82 (MAD Cohort)

• MTX-463 PK by dose will be evaluated for AUC0-∞, as feasible

  Blood serum samples will be collected at protocol-specified timepoints throughout the study

  Through Day 60 (SAD Cohort) or Day 82 (MAD Cohort)

Secondary Outcomes (2)

• Blood serum samples will be collected to determine the level of WISP1 engagement of MTX-463 in healthy adult participants

  Through Day 60 (SAD Cohort) or Day 82 (MAD Cohort)

• To assess the effect of baseline body mass index (BMI) on total and free WISP1 levels

  Through Day 60 (SAD Cohort) or Day 82 (MAD Cohort)

Other Outcomes (24)

• To assess the effect of MTX-463 on PD biomarker PRO-C3 for fibrosis in healthy adult participants

  Through Day 36 (MAD Cohort)

• To assess the effect of MTX-463 on PD biomarker PRO-C6 for fibrosis in healthy adult participants

  Through Day 36 (MAD Cohort)

• To assess the effect of MTX-463 on PD biomarker C7M for fibrosis in healthy adult participants

  Through Day 36 (MAD Cohort)

Study Arms (2)

MTX-463

EXPERIMENTAL

Biological: MTX-463

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

MTX-463 BIOLOGICAL

MTX-463 is an immunoglobin G1 (IgG1) monoclonal antibody directed against WNT-inducible signaling pathway protein 1 (WISP1). WISP1 (aka CCN-4) is a matricellular protein that appears to be upregulated locally in response to certain chronic diseases and malignancies.

MTX-463

Placebo OTHER

Matching Placebo-- Normal Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Mediar Therapeutics: lead
• ICON plc: collaborator

Study Sites (1)

ICON

Salt Lake City, Utah, 84124, United States

Location

Study Officials

• Ahad Sabet, MD

  ICON plc

  PRINCIPAL INVESTIGATOR

• Jeffrey Bornstein, MD

  Mediar Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: May 6, 2024
• Study Start: April 15, 2024
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)