Type 1 Diabetes (T1D) Clinical Trials

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Safety, Pharmacokinetics, and Pharmacodynamics of MTX-101 in Healthy Adults and Patients

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

First in human study to understand the potential side effects of MTX-101, how long MTX-101 lasts in the human body, and how MTX-101 affects specific human immune cells.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
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• 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 ≤ 35 kg/m2 AND body weight ≥ 55 and ≤ 120 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.

Locations
Other Locations
Australia
St Vincent's Hospital Melbourne (SVHM)
RECRUITING
Fitzroy
Austin Health
RECRUITING
Heidelberg
The Royal Melbourne Hospital
RECRUITING
Melbourne
Contact Information
Primary
Heather Director, Clinical Operations
hwroe@mozart-tx.com
1-253-358-9586
Time Frame
Start Date: 2024-06-13
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 96
Treatments
Placebo_comparator: Cohort AS1 - Healthy Volunteers
(n = 6): MTX-101, Dose level 1 IV or Placebo IV, Single dose
Placebo_comparator: Cohort AS2 - Healthy Volunteers
(n = 6): MTX-101, Dose Level 2 IV or Placebo IV, Single dose
Placebo_comparator: Cohort AS3 - Healthy Vounteers
(n = 6): MTX-101, Dose Level 3 IV or Placebo IV, single dose
Placebo_comparator: Cohort AS4 - Healthy Volunteers
(n =6): MTX-101, Dose Level 4 IV or Placebo IV, single dose
Placebo_comparator: Cohort AS5 - Healthy Volunteers
(n = 6): MTX-101, Dose level 6 IV or Placebo IV, Single Dose
Placebo_comparator: Cohort AM1 - Healthy Volunteers
Cohort AM1 (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 B8 - Type 1 Diabetes Patients
* Cohort B8 (n=12):~* MTX-101 up to Dose Group 4 IV Day 1 and 29
Experimental: Cohort B9 - Type 1 Diabetes Patients
Optional Cohort B9 (n=12):~• MTX-101 up to Dose 6 IV Day 1 and 29
Related Therapeutic Areas
Sponsors
Leads: Mozart Therapeutics Australia Pty Ltd

This content was sourced from clinicaltrials.gov