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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06324604




Registration number
NCT06324604
Ethics application status
Date submitted
27/02/2024
Date registered
22/03/2024

Titles & IDs
Public title
Safety, Pharmacokinetics, and Pharmacodynamics of MTX-101 in Healthy Adults and Patients
Scientific title
Safety, Pharmacokinetics, and Pharmacodynamics of MTX-101 in Healthy Adults and Patients
Secondary ID [1] 0 0
MT-101-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Celiac Disease 0 0
Type 1 Diabetes 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - MTX-101

Placebo comparator: Cohort A1S - Healthy Volunteers - Cohort A1S (n = 6): MTX-101, Dose level 1 IV or Placebo IV, Single dose

Placebo comparator: Cohort A2S - Healthy Volunteers - Cohort A2S (n = 6): MTX-101, Dose Level 2 IV or Placebo IV, Single dose

Placebo comparator: Cohort A3S - Healthy Vounteers - Cohort A3S (n = 6): MTX-101, Dose Level 3 IV or Placebo IV, single dose

Placebo comparator: Cohort A4S - Healthy Volunteers - Cohort A4S (n =6): MTX-101, Dose Level 4 IV or Placebo IV, single dose

Placebo comparator: Cohort A5Sa - Healthy Volunteers - Optional Cohort A5Sa (n = 6): MTX-101, Dose level 6 IV or Placebo IV, Single Dose

Placebo comparator: Cohort A6M - Healthy Volunteers - Cohort A5M (n=8): MTX-101,Dose Level 4 IV or Placebo IV, dosed on Days 1 and 22 for a total of 2 doses

Placebo comparator: Cohort A7M - Healthy Volunteers - Cohort A6M (n = 6): MTX-101, Dose Level 5 IV or Placebo IV, dosed on Days 1 and 22 for a total of 2 doses

Placebo comparator: Cohort A7Ma - Healthy Volunteers - Optional Cohort A6Ma (n = 6): Dose Level 6 IV or Placebo IV, dosed on Days 1 and 22 for a total of 2 doses

Placebo comparator: Cohort B8 - Celiac Disease or Type 1 Diabetes Patients - * Dose Group 1 (n = 6): MTX-101 Dose Level 4 IV Day 1, placebo IV Day 22
* Dose Group 2 (n = 6): Placebo IV Day 1, MTX-101 Dose Level 3 IV Day 22

Placebo comparator: Cohort B9 -Celiac Disease or Type 1 Diabetes Patients - Dose Group 1 (n = 6): MTX-101 Dose Level 5 IV Day 1, placebo IV Day 22 Dose Group 2 (n = 6): Placebo IV Day 1, MTX-101 Dose Level 5 IV (or the maximum tolerated dose in Part A MAD) Day 22

Placebo comparator: Cohort A5Sa -Healthy Volunteers - Optional Cohort A5Sa (n = 6): MTX-101, up to Dose Level 6 IV or Placebo IV, Single Dose


Treatment: Drugs: Placebo
Placebo

Treatment: Drugs: MTX-101
MTX-101 (bispecific CD8 Treg modulator)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety of single, ascending dose levels of MTX-101
Timepoint [1] 0 0
Enrollment to 8 weeks post dose
Primary outcome [2] 0 0
Safety of multiple, ascending dose levels of MTX-101
Timepoint [2] 0 0
Enrollment to 11 weeks following the last dose
Secondary outcome [1] 0 0
pharmacokinetics (PK) of MTX-101
Timepoint [1] 0 0
Enrollment to 11 weeks following the last dose
Secondary outcome [2] 0 0
pharmacokinetics (PK) of MTX-101
Timepoint [2] 0 0
Enrollment to 11 weeks following the last dose
Secondary outcome [3] 0 0
pharmacokinetics (PK) of MTX-101
Timepoint [3] 0 0
Enrollment to 11 weeks following the last dose
Secondary outcome [4] 0 0
anti-drug antibody (ADA) formation
Timepoint [4] 0 0
Enrollment to 11 weeks following the last dose

Eligibility
Key inclusion criteria
* Adults, age = 18 and = 65 years at the time of anticipated dosing (Day 1).
* Healthy individuals without known current or chronic medical conditions, including no history of any autoimmune diseases, in the opinion of the Investigator.
* Body mass index (BMI) = 18 kg/m2 and = 32 kg/m2.
* Body weight = 45and = 100 kg.
* Negative Coronavirus Disease 2019 (COVID-19) test within 24 hours prior to each dose.
* Persons of child-bearing potential must have a negative pregnancy test and either abstain from sex or use highly effective method(s) of birth control from Day 1 through the duration of the study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Clinically significant findings in physical examination (PE), vital signs (blood pressure, heart rate, and body temperature), electrocardiogram (ECG), and safety laboratory parameters at Screening in the opinion of the Investigator.
* Renal function calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation with estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m2 or abnormal level of proteinuria detected by dipstick at the time of Screening.
* Any disease or condition that, in the opinion of the Investigator, might significantly compromise the cardiovascular, hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems.
* Use of Anti-inflammatory OTC medications, e.g. acetaminophen and ibuprofen, taken within 1 week prior to and during the Screening period.
* Receipt of an investigational drug within 28 days or 5 half-lives (whichever is longer) of the investigational drug(s) prior to Day 1.
* Positive serology for human immunodeficiency virus (HIV) type 1 or 2, hepatitis (Hep) B surface antigen, or Hep C.
* Positive test results for drug screen, including alcohol, at the time of Screening or on Day 1 prior to randomization.
* Use of tobacco or nicotine-containing products more than the equivalent of 5 cigarettes/week within 30 days prior to (first) dosing.

Participants must abstain from nicotine use while inpatient.

* History of receiving a live vaccine within 1 month of Screening.
* History of splenectomy.
* History of COVID or influenza vaccine within 2 weeks prior to Screening.
* Planning to receive any vaccinations during the study period.
* History of recurrent infections of uncertain cause.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Nucleus Network Brisbane - Herston
Recruitment postcode(s) [1] 0 0
4006 - Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Mozart Therapeutics Australia Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Heather Director, Clinical Operations
Address 0 0
Country 0 0
Phone 0 0
1-253-358-9586
Fax 0 0
Email 0 0
hwroe@mozart-tx.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06324604