The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of MBX 2109 in healthy volunteers. This study includes 2 parts. Part A involves a single dose of MBX 2109 taken as a subcutaneous (SC) injection just under the skin. Part B involves repeat doses of MBX 2109 taken as a SC injection just under the skin. Each participant will enroll in only one part.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
76
Single ascending SC dose of MBX 2109: 50 µg, 150 µg, 300 µg, 460 µg, 600 µg
Repeated ascending SC doses of MBX 2109: 200 µg, 300 µg, 460 µg, 600 µg, 900 µg
Single SC dose or repeated SC doses of placebo.
Labcorp Drug Development: Clinical Research Unit
Dallas, Texas, United States
Labcorp Drug Development: Clinical Research Unit
Madison, Wisconsin, United States
Primary Outcome Measures
Number of participants with adverse events (AEs) or Serious Adverse Events (SAEs)
Time frame: Baseline through Day 40 (part A) or Day 60 (Part B)
Secondary Outcome Measures 1
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of MBX 2109
Time frame: Baseline through Day 40 (part A) or Day 60 (Part B)
Secondary Outcome Measures 2
Pharmacodynamics (PD): change from baseline in albumin corrected serum calcium
Time frame: Baseline through Day 40 (part A) or Day 60 (Part B)
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