The primary objective of this study is to evaluate the safety and tolerability of a single dose of ALRN-5281 administered by subcutaneous injection to healthy adult volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
33
Vince and Associates Clinical Research, LLC
Overland Park, Kansas, United States
Incidence of adverse events
Time frame: 28 days
Serum IGF-1
Time frame: Predose, Day 1-Day 28
Serum GH
Time frame: Predose, Day 1-Day 28
Time to Reach Maximum Observed Plasma Concentration (Tmax) of ALRN-5281
Time frame: Predose, Day 1- 0.5,1,2,3,4,6,8,10,12,14 and 16hr post dose , Day 2-Day11 and Day14
Maximum plasma concentration (Cmax) of ALRN-5281
Time frame: Predose, Day 1- 0.5,1,2,3,4,6,8,10,12,14 and 16hr post dose , Day 2-Day11 and Day14
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Time frame: Pre Dose, Day1- 0.5,1,2,3,4,6,8,10,12,14 and 16h post dose, Day2- Day11 and Day 14
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