Clinical trial NCT05862974: A Dose-escalation Study of LPM3480392 in Chinese Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Luye Pharma Group Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-17
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidents of AE (including SAE)
timeFrame: from baseline to day8
measure: DEQ
timeFrame: from baseline to day2
measure: OWS
timeFrame: from baseline to day3
Secondary outcomes:
measure: AUC0-t
timeFrame: baseline and 48 hours after administration
measure: AUC0-∞
timeFrame: baseline and 48 hours after administration
measure: Cmax
timeFrame: baseline and 48 hours after administration
measure: Tmax
timeFrame: baseline and 48 hours after administration
measure: T1/2
timeFrame: baseline and 48 hours after administration
measure: CL
timeFrame: baseline and 48 hours after administration
measure: Vd
timeFrame: baseline and 48 hours after administration
measure: MRT
timeFrame: baseline and 48 hours after administration
measure: λz
timeFrame: baseline and 48 hours after administration
measure: PD profile : Cold Pain Test
timeFrame: baseline and 8 hours after administration
measure: PD profile : Pupillometry
timeFrame: baseline and 8 hours after administration
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The second affiliated hosipital zhejiang university school of medicine
state: Zhejiang
Study officials:
References: