Study to assess the safety, pharmacokinetics (the amount of study drug or any of its breakdown products in your body) and pharmacodynamics (how the study drug affects your body) of RN3161 alone (healthy volunteers) and RN3161 with tirzepatide (overweight and obese subjects)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
104
Investigational Product
0.9% normal saline SC injection
In Part 3; randomized to either RN3161 + tirzepatide or placebo + tirzepatide
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia
RECRUITINGBlood Pressure
Number of participants with blood pressure changes measured in mmHg
Time frame: 180 Days
ECG PR interval
Number of participants with change in PR interval measured as milliseconds
Time frame: 180 days
Physical Examination
Number of participants with changes seen by physical examination of skin, lymph nodes, eyes, ears, throat, chest, abdomen, musculoskeletal system and nervous system
Time frame: 180 days
Blood Chemistry Laboratory
Number of participants with changes in blood levels of sodium, potassium, chloride, calcium magnesium, creatinine, bilirubin, phosphate, AST, ALT, alkaline phosphatase, glucose, albumin, urea in standard units
Time frame: 180 days
Adverse Events
Incidence of adverse events reported
Time frame: 180 days
Heart Rate
Number of participants with change in heart rate measured in beats per minute
Time frame: 180 days
ECG QRS Complex
Number of participants with changes in QRS complex measured in milliseconds
Time frame: 180 days
ECG QT interval
Number of participants with change in QT interval measured by Frederica method in milliseconds
Time frame: 180 days
Blood Hematology Laboratory
Number of participants with changes in blood hemoglobin, hematocrit, platelets, neutrophils and leukocytes measured in standard units
Time frame: 180 days
Blood Coagulation Laboratory
Number of participants with changes in plasma prothrombin time, activated partial thromboplastin time, and international normalized ratio measured in standard units
Time frame: 180 days
Plasma and Urine Pharmacokinetics
plasma and urine levels of RN3161
Time frame: 180 Days
Presence of ADA
incidence of anti-drug antibodies in the plasma
Time frame: 180 days
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