A Dose-escalation Study of LPM3480392 in Chinese Healthy Subjects

Sponsor

Luye Pharma Group Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT05862974

Collaborator

(none)

Enrollment

Location

Arms

8.2

Actual Duration (Months)

9.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: LPM3480392 Drug: Placebo	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 25, 2021

Actual Primary Completion Date :

Nov 2, 2021

Actual Study Completion Date :

Nov 2, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Incidents of AE (including SAE) [from baseline to day8]
(including abnormal value of Vital signs,physical examination,laboratory tests,12-lead ECG)
DEQ [from baseline to day2]
Drug effect questionnaire,
OWS [from baseline to day3]
Opiate Withdrawal Scale

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The second affiliated hosipital zhejiang university school of medicine	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

Luye Pharma Group Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Luye Pharma Group Ltd.

ClinicalTrials.gov Identifier:

NCT05862974

Other Study ID Numbers:

LY03014/CT-CHN-101

First Posted:

May 17, 2023

Last Update Posted:

May 17, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 17, 2023