The second affiliated hosipital zhejiang university school of medicine
Hangzhou, Zhejiang, 310000, China
NCT Number: NCT05857449
This study evaluated the safety, tolerability and PK/PD characteristics of LPM3480392 injection by intravenous infusion at different rates in healthy subjects.The experiment was divided into Part A and Part B.
Part A is a open label ,three cycle , fixed sequence dosing study .Twelve healthy male subjects were planned to be enrolled, and the same dose (X1mg)of LPM3480392 injection was intravenously injected at different infusion times in different drug administration cycles.
Part B is an open label ,two cycle , fixed sequence dosing study .Ten healthy male subjects (subjects not enrolled in Part A) were given LPM3480392 injection in 2 minutes , each subject was given X2mg at the first cycle and X3mg at the second cycle .
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Notify Me18 year–45 year
Male
Interventional
Phase 1
Hangzhou, Zhejiang, 310000, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous infusion
Time frame: from baseline to day7 of second or third cycle(each cycle is 4 days)
including abnormal value of Vital signs,physical examination,laboratory tests,12-lead ECG
Time frame: from baseline to day2 of second or third cycle(each cycle is 4 days)
Drug effect questionnaire
Time frame: from baseline to day7 of second or third cycle(each cycle is 4 days)
Opiate Withdrawal Scale
Time frame: baseline and within 24 hours after administration
Pharmacokinetic index
Time frame: baseline and within 24 hours after administration
Pharmacokinetic index
Time frame: baseline and within 24hours after administration
Pharmacokinetic index
Time frame: baseline and within 24 hours after administration
Pharmacokinetic index
Time frame: baseline and within 24 hours after administration
Pharmacokinetic index
Time frame: baseline and within24 hours after administration
Pharmacokinetic index
Time frame: baseline and within 24 hours after administration
Pharmacokinetic index
Time frame: baseline and within 24 hours after administration
Pharmacokinetic index
Time frame: baseline and within 24 hours after administration
Pharmacokinetic index
Time frame: baseline and within 8 hours after administration
Pharmacodynamic index
Time frame: baseline and within 8 hours after administration
Pharmacodynamic index
Luye Pharma Group Ltd.
Industry
To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LPM3480392 Injection at Different Rates in Healthy Subjects in a Phase I Clinical Trial
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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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