Healthy
Conditions
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.
Interventions
DRUGLPM3480392
Intravenous infusion of 30min duration
DRUGPlacebo
Intravenous infusion of 30min duration
Sponsors
Luye Pharma Group Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| AUC0-t | 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 |
| MRT | 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 |
Countries
China
Outcome results
None listed