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 (4) 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
View:

• 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
Wesley Research Institute
ACTIVE_NOT_RECRUITING
Auchenflower
Austin Health
RECRUITING
Heidelberg
The Royal Melbourne Hospital
RECRUITING
Melbourne
Austria
St Vincent's Hospital Melbourne (SVHM)
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