A Dose-escalation Study of LPM3480392 in Chinese Healthy Subjects

NCT ID: NCT05862974

Last Updated: 2023-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-25
• Study Completion Date: 2021-11-02

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LPM3480392 X1mg

8 subjects will receive LPM3480392 X1mg and 2 receive placebo

Group Type: EXPERIMENTAL

LPM3480392

Intervention Type: DRUG

Intravenous infusion of 30min duration

Placebo

Intervention Type: DRUG

Intravenous infusion of 30min duration

LPM3480392 X2mg

8 subjects will receive LPM3480392 X2 mg and 2 receive placebo

Group Type: EXPERIMENTAL

LPM3480392

Intervention Type: DRUG

Intravenous infusion of 30min duration

Placebo

Intervention Type: DRUG

Intravenous infusion of 30min duration

LPM3480392 X3mg

8 subjects will receive LPM3480392 X3mg and 2 receive placebo

Group Type: EXPERIMENTAL

LPM3480392

Intervention Type: DRUG

Intravenous infusion of 30min duration

Placebo

Intervention Type: DRUG

Intravenous infusion of 30min duration

LPM3480392 X4mg

8 subjects will receive LPM3480392 X4mg and 2 receive placebo

Group Type: EXPERIMENTAL

LPM3480392

Intervention Type: DRUG

Intravenous infusion of 30min duration

Placebo

Intervention Type: DRUG

Intravenous infusion of 30min duration

LPM3480392 X5mg

8 subjects will receive LPM3480392 X5mg and 2 receive placebo

Group Type: EXPERIMENTAL

LPM3480392

Intervention Type: DRUG

Intravenous infusion of 30min duration

Placebo

Intervention Type: DRUG

Intravenous infusion of 30min duration

LPM3480392 X6mg

8 subjects will receive LPM3480392 X6mg and 2 receive placebo

Group Type: EXPERIMENTAL

LPM3480392

Intervention Type: DRUG

Intravenous infusion of 30min duration

Placebo

Intervention Type: DRUG

Intravenous infusion of 30min duration

LPM3480392 X7mg

8 subjects will receive LPM3480392 X7mg and 2 receive placebo

Group Type: EXPERIMENTAL

LPM3480392

Intervention Type: DRUG

Intravenous infusion of 30min duration

Placebo

Intervention Type: DRUG

Intravenous infusion of 30min duration

LPM3480392 X8mg

8 subjects will receive LPM3480392 X8mg and 2 receive placebo

Group Type: EXPERIMENTAL

LPM3480392

Intervention Type: DRUG

Intravenous infusion of 30min duration

Placebo

Intervention Type: DRUG

Intravenous infusion of 30min duration

Interventions

LPM3480392

Intravenous infusion of 30min duration

Intervention Type: DRUG

Placebo

Intravenous infusion of 30min duration

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Luye Pharma Group Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The second affiliated hosipital zhejiang university school of medicine

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

LY03014/CT-CHN-101

Identifier Type: -

Identifier Source: org_study_id