The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses and Drug Drug Interaction of MBX 1416 in healthy volunteers This study includes 3 parts. Part A involves a single dose of MBX 1416 or placebo taken as a subcutaneous injection (SC). Part B involves repeat doses of MBX 1416 or placebo taken as a subcutaneous injection (SC). Part C involves the evaluation of rosuvastatin and acetaminophen pharmacokinetics in the presence and absence of MBX 1416.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
69
Single Ascending subcutaneous (SC) dose of MBX 1416: 10mg, 30mg,100mg, 200mg
Repeated ascending subcutaneous (SC) doses of MBX 1416: 10mg, 30mg, 100mg
Single dose or repeated subcutaneous (SC) dose of placebo.
MBX Biosciences Investigational Site
Chula Vista, California, United States
Number of participants with adverse events (AEs), Serious Adverse Events (SAEs)
Time frame: Baseline through Day 29 (Part A) or Day 45 (Part B) and Day 21 (Part C)
Maximum Plasma Concentration (Cmax)
Time frame: Baseline through Day 29 (Part A) or Day 45 (Part B) and Day 21 (Part C)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Single subcutaneous (SC) dose of MBX 1416 and the single dose of rosuvastatin and acetaminophen pharmacokinetics. The doses selected for MBX 1416 in Part C will not exceed a dose of 200mg.