A Dose-escalation Study of LPM3480392 in Chinese Healthy Subjects

Luye Pharma Group

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LPM3480392; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05862974

LY03014/CT-CHN-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 8 patient groups

LPM3480392 X1mg

Experimental group

Description:

8 subjects will receive LPM3480392 X1mg and 2 receive placebo

Treatment:

Drug: LPM3480392

Drug: Placebo

LPM3480392 X2mg

Experimental group

Description:

8 subjects will receive LPM3480392 X2 mg and 2 receive placebo

Treatment:

Drug: LPM3480392

Drug: Placebo

LPM3480392 X3mg

Experimental group

Description:

8 subjects will receive LPM3480392 X3mg and 2 receive placebo

Treatment:

Drug: LPM3480392

Drug: Placebo

LPM3480392 X4mg

Experimental group

Description:

8 subjects will receive LPM3480392 X4mg and 2 receive placebo

Treatment:

Drug: LPM3480392

Drug: Placebo

LPM3480392 X5mg

Experimental group

Description:

8 subjects will receive LPM3480392 X5mg and 2 receive placebo

Treatment:

Drug: LPM3480392

Drug: Placebo

LPM3480392 X6mg

Experimental group

Description:

8 subjects will receive LPM3480392 X6mg and 2 receive placebo

Treatment:

Drug: LPM3480392

Drug: Placebo

LPM3480392 X7mg

Experimental group

Description:

8 subjects will receive LPM3480392 X7mg and 2 receive placebo

Treatment:

Drug: LPM3480392

Drug: Placebo

LPM3480392 X8mg

Experimental group

Description:

8 subjects will receive LPM3480392 X8mg and 2 receive placebo

Treatment:

Drug: LPM3480392

Drug: Placebo