A Dose-escalation Study of LPM3480392 in Chinese Healthy Subjects

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05862974
• Other study ID #: LY03014/CT-CHN-101
• Status: Completed
• Phase: Phase 1
• Start date: February 25, 2021
• Est. completion date: November 2, 2021

Study information

• Verified date: May 2023
• Source: Luye Pharma Group Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2, 2021
• Est. primary completion date: November 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LPM3480392
Intravenous infusion of 30min duration
• Placebo
Intravenous infusion of 30min duration

Locations

Country	Name	City	State
China	The second affiliated hosipital zhejiang university school of medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Luye Pharma Group Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidents of AE (including SAE)	(including abnormal value of Vital signs,physical examination,laboratory tests,12-lead ECG)	from baseline to day8
Primary	DEQ	Drug effect questionnaire,	from baseline to day2
Primary	OWS	Opiate Withdrawal Scale	from baseline to day3
Secondary	AUC0-t	Pharmacokinetic index	baseline and 48 hours after administration
Secondary	AUC0-8	Pharmacokinetic index	baseline and 48 hours after administration
Secondary	Cmax	Pharmacokinetic index	baseline and 48 hours after administration
Secondary	Tmax	Pharmacokinetic index	baseline and 48 hours after administration
Secondary	T1/2	Pharmacokinetic index	baseline and 48 hours after administration
Secondary	CL	Pharmacokinetic index	baseline and 48 hours after administration
Secondary	Vd	Pharmacokinetic index	baseline and 48 hours after administration
Secondary	MRT	Pharmacokinetic index	baseline and 48 hours after administration
Secondary	?z	Pharmacokinetic index	baseline and 48 hours after administration
Secondary	PD profile : Cold Pain Test	Pharmacodynamic index	baseline and 8 hours after administration
Secondary	PD profile : Pupillometry	Pharmacodynamic index	baseline and 8 hours after administration