Evaluation of MTX-439 in Healthy Adults and Adults With Diabetic Kidney Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMediar Therapeutics
About this trial
This is a phase 1 randomized, double-blind, single ascending dose (SAD) and multiple ascending dose (MAD) study to assess the safety, tolerability, and Pharmacokinetics (PK) of single and multiple ascending doses of MTX-439 administered in healthy adults and adults with diabetic kidney disease (DKD)
Eligibility criteria
Qualifiers
All genders, ages 18 to 65 years, inclusive.
Able to read and understand the study and all related materials (including the ICF), and provide a signed, written informed consent.
Willing and able to complete all protocol-required study visits and procedures.
Consumption of no more than 5 cigarettes or other cotinine-containing products (including tobacco, nicotine gum, patches, nicotine pouches, and e-cigarettes) per week and agreement to abstain from all such products during inpatient stays.
Disqualifiers
Any active medical condition determined clinically significant by the Investigator, except for DKD (for DKD participants).
Body mass index (BMI) > 32 kg/m2 for healthy participants; > 40 kg/m2 for DKD participants.
Use of any systemic immunosuppressant medications, medications to treat diabetes (except DKD participants), antipsychotics, anticoagulants, or other prescription medications other than contraceptives within 90 days of Screening that, as determined by the Investigator, could confound their participation in the study.
Received a vaccine within 30 days of Screening.
Trial design
Treatments tested in this trial
- MTX-439
- Placebo
Treatment groups
88 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov