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
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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 ≤ 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.
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 - Celiac Disease or Type 1 Diabetes Patients
* Dose Group 1 (n = 6): MTX-101 Dose Level 4 IV Day 1 and 29, placebo IV Day 57~* Dose Group 2 (n = 6): Placebo IV Day 1, MTX-101 Dose Level 3 IV Day 29 and 57
Placebo_comparator: Cohort B9 -Celiac Disease or Type 1 Diabetes Patients
Dose Group 1 (n = 6): MTX-101 Dose Level 5 IV Days 1 and 29 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 29