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Completed

NCT Number: NCT05857449

An Exploratory Study of LPM3480392 at Different Infusion Rates in Chinese Healthy Subjects

This study evaluated the safety, tolerability and PK/PD characteristics of LPM3480392 injection by intravenous infusion at different rates in healthy subjects.The experiment was divided into Part A and Part B.

Part A is a open label ,three cycle , fixed sequence dosing study .Twelve healthy male subjects were planned to be enrolled, and the same dose (X1mg)of LPM3480392 injection was intravenously injected at different infusion times in different drug administration cycles.

Part B is an open label ,two cycle , fixed sequence dosing study .Ten healthy male subjects (subjects not enrolled in Part A) were given LPM3480392 injection in 2 minutes , each subject was given X2mg at the first cycle and X3mg at the second cycle .

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The second affiliated hosipital zhejiang university school of medicine

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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℃ (± 0.3℃) 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 substance 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;

Treatment and study plan

LPM3480392

Drug

Intravenous infusion

Primary outcomes

  1. Incidents of AE (including SAE)

    Time frame: from baseline to day7 of second or third cycle(each cycle is 4 days)

    including abnormal value of Vital signs,physical examination,laboratory tests,12-lead ECG

  2. DEQ scores

    Time frame: from baseline to day2 of second or third cycle(each cycle is 4 days)

    Drug effect questionnaire

  3. OWS scores

    Time frame: from baseline to day7 of second or third cycle(each cycle is 4 days)

    Opiate Withdrawal Scale

Secondary outcomes

  1. AUC0-t

    Time frame: baseline and within 24 hours after administration

    Pharmacokinetic index

  2. AUC0-∞

    Time frame: baseline and within 24 hours after administration

    Pharmacokinetic index

  3. Cmax

    Time frame: baseline and within 24hours after administration

    Pharmacokinetic index

  4. Tmax

    Time frame: baseline and within 24 hours after administration

    Pharmacokinetic index

  5. T1/2

    Time frame: baseline and within 24 hours after administration

    Pharmacokinetic index

  6. CL

    Time frame: baseline and within24 hours after administration

    Pharmacokinetic index

  7. Vd

    Time frame: baseline and within 24 hours after administration

    Pharmacokinetic index

  8. MRT

    Time frame: baseline and within 24 hours after administration

    Pharmacokinetic index

  9. λz

    Time frame: baseline and within 24 hours after administration

    Pharmacokinetic index

  10. Cold Pain Test

    Time frame: baseline and within 8 hours after administration

    Pharmacodynamic index

  11. Pupillometry

    Time frame: baseline and within 8 hours after administration

    Pharmacodynamic index

Sponsors and collaborators

Lead sponsor

Luye Pharma Group Ltd.

Industry

Registry information

Official study title

To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LPM3480392 Injection at Different Rates in Healthy Subjects in a Phase I Clinical Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 12, 2023
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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