An Exploratory Study of LPM3480392 at Different Infusion Rates in Chinese Healthy Subjects

To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LPM3480392 Injection at Different Rates in Healthy Subjects in a Phase I Clinical Trial

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 .

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LPM3480392

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • The Second Affiliated Hosipital Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• The subject voluntarily signs the informed consent.
• Healthy male, aged 18-45 years (including boundary values);
• Body mass index (BMI) 19-26kg/m2 (including boundary value), weight ≥50kg;
• Subjects are willing to take contraceptive measures and promise not to donate sperm during the study period and within 90 days after administration;
• Willing to accept cold pain test, and the non-dominant hand can be soaked in ice water bath at 2℃ (± 0.3℃) for > 10s, < 120s;

Exclusion Criteria:

• Known history of allergy to any component of the investigational product or similar drugs, or allergic constitution [subjects with previous allergy to two or more foods or drugs];
• Past or present with any clinically significant disease or chronic disease of the respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, endocrine system, immune system, hematology, psychiatry, dermatology, orthostatic hypotension, etc.; or any disease that may interfere with the test results or interpretation of the results;
• Patients with Raynaud's syndrome;
• The skin wounds or skin diseases that may affect the cold pain test results; Sitting systolic blood pressure (SBP) < 90 mmHg, ≥ 140 mmHg or diastolic blood pressure (DBP) < 60 mmHg, ≥ 90 mmHg; subjects with heart rate < 60 beats/min, > 100 beats/min;
• QTc > 450 ms on electrocardiogram;
• Positive urine nicotine test;
• History of alcohol abuse within 3 months prior to Screening, defined as consumption of more than 14 units of alcohol per week (1 unit = 360 mL of beer, or 45 mL of spirits of 40% alcohol content, or 150 mL of wine), or a positive breath alcohol result;
• History of substance abuse or drug abuse or positive result of urine drug screening;
• Those who consume more than 100 g of xanthine-rich foods such as chocolate per day on average; those who consume more than 100 g of foods containing grapefruit and/or pomelo; those who consume more than 1000 mL of strong tea, coffee, cola and beverages containing caffeine and/or grapefruit ingredients;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A; Each subject receive the same dose(X1mg) of LPM3480392 in 15minutes in the first cycle, 5 minutes in the second cycle, and 2 minutes in the third cycle .	Drug: LPM3480392; Intravenous infusion
Experimental: Part B; Each subject receive LPM3480392 X2mg in the first cycle and LPM3480392 X3mg in the second cycle .	Drug: LPM3480392; Intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidents of AE (including SAE)	including abnormal value of Vital signs,physical examination,laboratory tests,12-lead ECG	from baseline to day7 of second or third cycle(each cycle is 4 days)
DEQ scores	Drug effect questionnaire	from baseline to day2 of second or third cycle(each cycle is 4 days)
OWS scores	Opiate Withdrawal Scale	from baseline to day7 of second or third cycle(each cycle is 4 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-t	Pharmacokinetic index	baseline and within 24 hours after administration
AUC0-∞	Pharmacokinetic index	baseline and within 24 hours after administration
Cmax	Pharmacokinetic index	baseline and within 24hours after administration
Tmax	Pharmacokinetic index	baseline and within 24 hours after administration
T1/2	Pharmacokinetic index	baseline and within 24 hours after administration
CL	Pharmacokinetic index	baseline and within24 hours after administration
Vd	Pharmacokinetic index	baseline and within 24 hours after administration
MRT	Pharmacokinetic index	baseline and within 24 hours after administration
λz	Pharmacokinetic index	baseline and within 24 hours after administration
Cold Pain Test	Pharmacodynamic index	baseline and within 8 hours after administration
Pupillometry	Pharmacodynamic index	baseline and within 8 hours after administration

Collaborators and Investigators

• Sponsor: Luye Pharma Group Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2021
• Primary Completion (Actual): March 9, 2022
• Study Completion (Actual): March 9, 2022

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 12, 2023

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: LY03014/CT-CHN-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No