A Dose-escalation Study of LPM3480392 in Chinese Healthy Subjects
- Registration Number
- NCT05862974
- Lead Sponsor
- Luye Pharma Group Ltd.
- 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 80
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LPM3480392 X3mg Placebo 8 subjects will receive LPM3480392 X3mg and 2 receive placebo LPM3480392 X4mg LPM3480392 8 subjects will receive LPM3480392 X4mg and 2 receive placebo LPM3480392 X4mg Placebo 8 subjects will receive LPM3480392 X4mg and 2 receive placebo LPM3480392 X2mg LPM3480392 8 subjects will receive LPM3480392 X2 mg and 2 receive placebo LPM3480392 X2mg Placebo 8 subjects will receive LPM3480392 X2 mg and 2 receive placebo LPM3480392 X3mg LPM3480392 8 subjects will receive LPM3480392 X3mg and 2 receive placebo LPM3480392 X6mg Placebo 8 subjects will receive LPM3480392 X6mg and 2 receive placebo LPM3480392 X1mg Placebo 8 subjects will receive LPM3480392 X1mg and 2 receive placebo LPM3480392 X5mg Placebo 8 subjects will receive LPM3480392 X5mg and 2 receive placebo LPM3480392 X6mg LPM3480392 8 subjects will receive LPM3480392 X6mg and 2 receive placebo LPM3480392 X7mg LPM3480392 8 subjects will receive LPM3480392 X7mg and 2 receive placebo LPM3480392 X7mg Placebo 8 subjects will receive LPM3480392 X7mg and 2 receive placebo LPM3480392 X8mg LPM3480392 8 subjects will receive LPM3480392 X8mg and 2 receive placebo LPM3480392 X8mg Placebo 8 subjects will receive LPM3480392 X8mg and 2 receive placebo LPM3480392 X1mg LPM3480392 8 subjects will receive LPM3480392 X1mg and 2 receive placebo LPM3480392 X5mg LPM3480392 8 subjects will receive LPM3480392 X5mg and 2 receive placebo
- Primary Outcome Measures
Name Time Method DEQ from baseline to day2 Drug effect questionnaire,
Incidents of AE (including SAE) from baseline to day8 (including abnormal value of Vital signs,physical examination,laboratory tests,12-lead ECG)
OWS from baseline to day3 Opiate Withdrawal Scale
- Secondary Outcome Measures
Name Time Method 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
AUC0-t baseline and 48 hours after administration Pharmacokinetic index
PD profile : Pupillometry baseline and 8 hours after administration Pharmacodynamic 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
Trial Locations
- Locations (1)
The second affiliated hosipital zhejiang university school of medicine
🇨🇳Hangzhou, Zhejiang, China