A Dose-escalation Study of LPM3480392 in Chinese Healthy Subjects

A Randomized, Double-blind, Placebo-controlled, Dose-increasing Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Intravenous Infusion of LPM3480392 Injection in Healthy Subject

This is a randomized, double-blind, placebo-controlled, dose-increasing Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single intravenous infusion of LPM3480392 injection in healthy subject

Study Overview

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

Detailed Description

A total of 80 healthy subjects will be allocated to 1 of 8 cohorts (cohort 1~8) in the study, each cohort including 10 subjects (8 subjects will receive investigational new drug (IND) product and 2 receive placebo). Each subject in fasted state will be randomly assigned to receive a single dose of LPM3480392 or placebo intravenously.

• Study Type: Interventional
• Enrollment (Actual): 80
• 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℃ (± 0.2℃) 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 drug 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: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LPM3480392 X1mg; 8 subjects will receive LPM3480392 X1mg and 2 receive placebo	Drug: LPM3480392; Intravenous infusion of 30min duration; Drug: Placebo; Intravenous infusion of 30min duration
Experimental: LPM3480392 X2mg; 8 subjects will receive LPM3480392 X2 mg and 2 receive placebo	Drug: LPM3480392; Intravenous infusion of 30min duration; Drug: Placebo; Intravenous infusion of 30min duration
Experimental: LPM3480392 X3mg; 8 subjects will receive LPM3480392 X3mg and 2 receive placebo	Drug: LPM3480392; Intravenous infusion of 30min duration; Drug: Placebo; Intravenous infusion of 30min duration
Experimental: LPM3480392 X4mg; 8 subjects will receive LPM3480392 X4mg and 2 receive placebo	Drug: LPM3480392; Intravenous infusion of 30min duration; Drug: Placebo; Intravenous infusion of 30min duration
Experimental: LPM3480392 X5mg; 8 subjects will receive LPM3480392 X5mg and 2 receive placebo	Drug: LPM3480392; Intravenous infusion of 30min duration; Drug: Placebo; Intravenous infusion of 30min duration
Experimental: LPM3480392 X6mg; 8 subjects will receive LPM3480392 X6mg and 2 receive placebo	Drug: LPM3480392; Intravenous infusion of 30min duration; Drug: Placebo; Intravenous infusion of 30min duration
Experimental: LPM3480392 X7mg; 8 subjects will receive LPM3480392 X7mg and 2 receive placebo	Drug: LPM3480392; Intravenous infusion of 30min duration; Drug: Placebo; Intravenous infusion of 30min duration
Experimental: LPM3480392 X8mg; 8 subjects will receive LPM3480392 X8mg and 2 receive placebo	Drug: LPM3480392; Intravenous infusion of 30min duration; Drug: Placebo; Intravenous infusion of 30min duration

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 day8
DEQ	Drug effect questionnaire,	from baseline to day2
OWS	Opiate Withdrawal Scale	from baseline to day3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-t	Pharmacokinetic index	baseline and 48 hours after administration
AUC0-∞	Pharmacokinetic index	baseline and 48 hours after administration
Cmax	Pharmacokinetic index	baseline and 48 hours after administration
Tmax	Pharmacokinetic index	baseline and 48 hours after administration
T1/2	Pharmacokinetic index	baseline and 48 hours after administration
CL	Pharmacokinetic index	baseline and 48 hours after administration
Vd	Pharmacokinetic index	baseline and 48 hours after administration
MRT	Pharmacokinetic index	baseline and 48 hours after administration
λz	Pharmacokinetic index	baseline and 48 hours after administration
PD profile : Cold Pain Test	Pharmacodynamic index	baseline and 8 hours after administration
PD profile : Pupillometry	Pharmacodynamic index	baseline and 8 hours after administration

Collaborators and Investigators

• Sponsor: Luye Pharma Group Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2021
• Primary Completion (Actual): November 2, 2021
• Study Completion (Actual): November 2, 2021

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: LY03014/CT-CHN-101

Drug and device information, study documents

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