Covance CRU
Dallas, Texas, 75247, United States
NCT Number: NCT03279302
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
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Dallas, Texas, 75247, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Solution for injection
Other names: ZP1848
Time frame: Day 0 up to Day 73
Half life of glepaglutide and active metabolites
Time frame: Day 0 to Day 22
Total body clearance after IV administration
Time frame: Day 0 to Day 73
CL/F for subcutaneous doses
Time frame: Day 0- Day 22
Volume of distribution after IV dosing
Time frame: Day 0 to Day 73
Vss/F and Vz/F for subcutaneous doses
Time frame: Day 0 to Day 73
Maximum observed plasma concentration
Time frame: Day 0 to Day 73
time of maximum observed plasma concentration
Time frame: Day 0 to Day 73
Area under the curve
Time frame: Day 0 to Day 73
change in plasma citrulline levels
Time frame: Day 0 to Day 73
Overall incidence of anti-glepaglutide antibodies
Time frame: Day 0 to Day 73
Incidence, nature, and severity of adverse events, abnormal clinical laboratory tests, and injection site reactions
Time frame: Day 0 to Day 73
12 lead electrocardiogram parameters
Zealand Pharma
Industry
A Phase 1, Open-Label, Partially Randomized, 3-Part, Parallel Group Trial to Evaluate the Pharmacokinetic Profile of Glepaglutide (ZP1848) After a Single Intravenous Injection and After Multiple Subcutaneous Injections in Healthy Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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