HealthyPhase 1NCT06401213
A First-in-Human Safety Trial of MTX-463
A Phase 1 study testing MTX-463 in people with Healthy, run by Mediar Therapeutics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MTX-463
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2024to 15 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- - 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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 doses of MTX-463 administered in healthy adults.
SAD Portion
The SAD portion of the study will consist of 4 planned dosing cohorts each comprising 8 healthy participants. The starting dose will be 4 mg/kg (Cohort 1) with subsequent planned doses of 8 mg/kg (Cohort 2), 16 mg/kg (Cohort 3), and 30 mg/kg (Cohort 4). Planned doses may be adjusted in response to the data. Additional participants and/or additional dosing cohorts may be added as needed based on the data.
Within each cohort, participants will be randomly assigned to receive MTX-463 or matched placebo. The first 2 participants (sentinel participants) within each cohort will be randomized 1:1 to receive MTX-463 or placebo on Day 1. These participants will be monitored for 24 hours, and after review of the safety data from both participants and approval by the study Investigator and Sponsor's responsible medical officer (SRMO), the additional 6 participants will be randomized to study drug (n=5 MTX-463; n=1 placebo).
Each participant will undergo assessments at specified timepoints on Days 1 through 60. End-of-Study (EOS) procedures will be completed on Day 28 or upon early termination (ET). An End-of-Follow-up (EOF) assessment of PK and ADA will be completed on Day 60.
MAD Portion
The MAD portion of the study will consist of 3 planned dosing cohorts. Each cohort will comprise 8 healthy participants (n=6 MTX-463; n=2 placebo). The starting dose will be a 6.6 mg/kg loading dose and 4 mg/kg maintenance doses (Cohort 1) with subsequent planned doses of a 13 mg/kg loading dose and 8 mg/kg maintenance doses (Cohort 2), and a 27 mg/kg loading dose and 16 mg/kg maintenance doses (Cohort 3). Planned doses may be adjusted in response to the data. Additional participants and/or additional dosing cohorts may be added as needed based on the data.
On Day 1, participants will be randomized to receive either MTX-463 or matched placebo. The randomized participants will receive a single loading dose on Day 1 followed by 2 maintenance doses of study drug on Day 8 and Day 22. Participants will be housed inpatient from Day -1 through post-dose observation on Day 8 and from Day 21 through assessments on Day 29. All other visits will be conducted in the outpatient setting. Each participant will undergo assessments at specified timepoints on Days 1 through 82. End-of-study procedures will be completed on Day 50, or upon ET. An EOF assessment of PK and ADA will be completed on Day 82.
Safety and tolerability of MTX-463 will be reviewed through Day 29 by the study Investigator and SRMO to inform dose escalation decisions for the next dose cohort.
Additional cohorts for the SAD and MAD portions of the study may be added as needed to potentially explore lower doses.
- Conditions
- Healthy
- Being tested
- MTX-463, Placebo
- Keywords
- HEALTHY VOLUNTEER, SAD, MAD, MTX-463-I101, MTX-463, WISP-1, ADULT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTX-463Biological
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.
PlaceboOther
Matching Placebo-- Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| MTX-463 | Experimental | Not described Receives: Biological: MTX-463 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
These assessments will be summarized as:
- Change from Baseline in total WISP1 levels
- Change from Baseline in free WISP1 levels
Measured: 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
Baseline levels and change from Baseline of the total and free WISP1 levels will be compared in those with BMIs ≥30 kg/m2 to those with BMIs <30 kg/m2.
Measured: Through Day 60 (SAD Cohort) or Day 82 (MAD Cohort)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start15 Apr 2024
- Primary completion15 Nov 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mediar Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Responsible party
- Sponsor
- Investigators
- Ahad Sabet, MD, Principal investigator, ICON plcJeffrey Bornstein, MD, Study director, Mediar Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401213
- Sponsor's protocol ID
- MTX-463-I101
- Status last verified
- Jan 2025
- First submitted
- 22 Apr 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06401213
- Acronym / sponsor ID
- MTX-463-I101
- Conditions
- Healthy
- Keywords
- HEALTHY VOLUNTEER, SAD, MAD, MTX-463-I101, MTX-463, WISP-1, ADULT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Mediar TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- ICON plc
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 doses of MTX-463 administered in healthy adults.
SAD Portion
The SAD portion of the study will consist of 4 planned dosing cohorts each comprising 8 healthy participants. The starting dose will be 4 mg/kg (Cohort 1) with subsequent planned doses of 8 mg/kg (Cohort 2), 16 mg/kg (Cohort 3), and 30 mg/kg (Cohort 4). Planned doses may be adjusted in response to the data. Additional participants and/or additional dosing cohorts may be added as needed based on the data.
Within each cohort, participants will be randomly assigned to receive MTX-463 or matched placebo. The first 2 participants (sentinel participants) within each cohort will be randomized 1:1 to receive MTX-463 or placebo on Day 1. These participants will be monitored for 24 hours, and after review of the safety data from both participants and approval by the study Investigator and Sponsor's responsible medical officer (SRMO), the additional 6 participants will be randomized to study drug (n=5 MTX-463; n=1 placebo).
Each participant will undergo assessments at specified timepoints on Days 1 through 60. End-of-Study (EOS) procedures will be completed on Day 28 or upon early termination (ET). An End-of-Follow-up (EOF) assessment of PK and ADA will be completed on Day 60.
MAD Portion
The MAD portion of the study will consist of 3 planned dosing cohorts. Each cohort will comprise 8 healthy participants (n=6 MTX-463; n=2 placebo). The starting dose will be a 6.6 mg/kg loading dose and 4 mg/kg maintenance doses (Cohort 1) with subsequent planned doses of a 13 mg/kg loading dose and 8 mg/kg maintenance doses (Cohort 2), and a 27 mg/kg loading dose and 16 mg/kg maintenance doses (Cohort 3). Planned doses may be adjusted in response to the data. Additional participants and/or additional dosing cohorts may be added as needed based on the data.
On Day 1, participants will be randomized to receive either MTX-463 or matched placebo. The randomized participants will receive a single loading dose on Day 1 followed by 2 maintenance doses of study drug on Day 8 and Day 22. Participants will be housed inpatient from Day -1 through post-dose observation on Day 8 and from Day 21 through assessments on Day 29. All other visits will be conducted in the outpatient setting. Each participant will undergo assessments at specified timepoints on Days 1 through 82. End-of-study procedures will be completed on Day 50, or upon ET. An EOF assessment of PK and ADA will be completed on Day 82.
Safety and tolerability of MTX-463 will be reviewed through Day 29 by the study Investigator and SRMO to inform dose escalation decisions for the next dose cohort.
Additional cohorts for the SAD and MAD portions of the study may be added as needed to potentially explore lower doses.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTX-463 | Experimental | Biological: MTX-463 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MTX-463MTX-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. | Biological | MTX-463 |
| PlaceboMatching Placebo-- Normal Saline | Other | Placebo |
Primary outcome
Incidence of Treatment-Related Adverse Events in healthy volunteers
Time frame: Through Day 60 (SAD Cohort) or Day 82 (MAD Cohort)
Clinical Safety Labs are collected, and Adverse Events are assessed in both inpatient and outpatient clinic visits
MTX-463 PK by dose will be evaluated for Cmax, as feasible
Time frame: Through Day 60 (SAD Cohort) or Day 82 (MAD Cohort)
Blood serum samples will be collected at protocol-specified timepoints throughout the study
Serum sample results will be summarized for presence of Anti-Drug Antibodies during the SAD and MAD portions of the study.
Time frame: Through Day 60 (SAD Cohort) or Day 82 (MAD Cohort)
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.
MTX-463 PK by dose will be evaluated for AUC0-t, as feasible.
Time frame: Through Day 60 (SAD Cohort) or Day 82 (MAD Cohort)
Blood serum samples will be collected at protocol-specified timepoints throughout the study
MTX-463 PK by dose will be evaluated for AUC0-tau (MAD only), as feasible
Time frame: Through Day 82 (MAD Cohort)
Blood serum samples will be collected at protocol-specified timepoints throughout the study
MTX-463 PK by dose will be evaluated for AUC0-∞, as feasible
Time frame: Through Day 60 (SAD Cohort) or Day 82 (MAD Cohort)
Blood serum samples will be collected at protocol-specified timepoints throughout the study
2 secondary outcomes
Blood serum samples will be collected to determine the level of WISP1 engagement of MTX-463 in healthy adult participants
Time frame: 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
Time frame: Through Day 60 (SAD Cohort) or Day 82 (MAD Cohort)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahad Sabet, MD principal investigator
ICON plc
Jeffrey Bornstein, MD study director
Mediar Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MTX-463 in people with Healthy, run by Mediar Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Related Adverse Events in healthy volunteers (time frame: Through Day 60 (SAD Cohort) or Day 82 (MAD Cohort)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.