The primary objective of the trial is to characterize the pharmacokinetic (PK) profiles of glepaglutide and its primary active metabolites following once-daily and once-weekly subcutaneous (SC) injections and after a single intravenous (IV) infusion in healthy subjects. Glepaglutide is a proposed International Nonproprietary Name for ZP1848
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Solution for injection
Covance CRU
Dallas, Texas, United States
Pharmacokinetic parameter - half life
Half life of glepaglutide and active metabolites
Time frame: Day 0 up to Day 73
Pharmacokinetic parameter - total body clearance
Total body clearance after IV administration
Time frame: Day 0 to Day 22
Pharmacokinetic parameter - Apparent clearance
CL/F for subcutaneous doses
Time frame: Day 0 to Day 73
Pharmacokinetic parameter - Volume of distribution
Volume of distribution after IV dosing
Time frame: Day 0- Day 22
Pharmacokinetic parameter - apparent volume of distribution
Vss/F and Vz/F for subcutaneous doses
Time frame: Day 0 to Day 73
Pharmacokinetic parameter - Cmax
Maximum observed plasma concentration
Time frame: Day 0 to Day 73
Pharmacokinetic parameter - tmax
time of maximum observed plasma concentration
Time frame: Day 0 to Day 73
Pharmacokinetic parameter - AUC
Area under the curve
Time frame: Day 0 to Day 73
Pharmacodynamic parameter - plasma citrulline levels
change in plasma citrulline levels
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Time frame: Day 0 to Day 73
ADA incidence
Overall incidence of anti-glepaglutide antibodies
Time frame: Day 0 to Day 73
Safety and tolerability - AEs
Incidence, nature, and severity of adverse events, abnormal clinical laboratory tests, and injection site reactions
Time frame: Day 0 to Day 73
Safety and tolerability - ECGs
12 lead electrocardiogram parameters
Time frame: Day 0 to Day 73