A Dose-escalation Study of LPM3480392 in Chinese Healthy Subjects

NCT05862974 | Completed Phase 1

• 1 other identifier: LY03014/CT-CHN-101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Incidents of AE (including SAE)

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

  from baseline to day8

• DEQ

  Drug effect questionnaire,

  from baseline to day2

• OWS

  Opiate Withdrawal Scale

  from baseline to day3

Secondary Outcomes (11)

• AUC0-t

  baseline and 48 hours after administration

• AUC0-∞

  baseline and 48 hours after administration

• Cmax

  baseline and 48 hours after administration

• Tmax

  baseline and 48 hours after administration

• T1/2

  baseline and 48 hours after administration

Study Arms (8)

LPM3480392 X1mg

EXPERIMENTAL

8 subjects will receive LPM3480392 X1mg and 2 receive placebo

Drug: LPM3480392; Drug: Placebo

LPM3480392 X2mg

EXPERIMENTAL

8 subjects will receive LPM3480392 X2 mg and 2 receive placebo

Drug: LPM3480392; Drug: Placebo

LPM3480392 X3mg

EXPERIMENTAL

8 subjects will receive LPM3480392 X3mg and 2 receive placebo

Drug: LPM3480392; Drug: Placebo

LPM3480392 X4mg

EXPERIMENTAL

8 subjects will receive LPM3480392 X4mg and 2 receive placebo

Drug: LPM3480392; Drug: Placebo

LPM3480392 X5mg

EXPERIMENTAL

8 subjects will receive LPM3480392 X5mg and 2 receive placebo

Drug: LPM3480392; Drug: Placebo

LPM3480392 X6mg

EXPERIMENTAL

8 subjects will receive LPM3480392 X6mg and 2 receive placebo

Drug: LPM3480392; Drug: Placebo

LPM3480392 X7mg

EXPERIMENTAL

8 subjects will receive LPM3480392 X7mg and 2 receive placebo

Drug: LPM3480392; Drug: Placebo

LPM3480392 X8mg

EXPERIMENTAL

8 subjects will receive LPM3480392 X8mg and 2 receive placebo

Drug: LPM3480392; Drug: Placebo

Interventions

LPM3480392 DRUG

Intravenous infusion of 30min duration

LPM3480392 X1mg; LPM3480392 X2mg; LPM3480392 X3mg; LPM3480392 X4mg; LPM3480392 X5mg; LPM3480392 X6mg; LPM3480392 X7mg; LPM3480392 X8mg

Placebo DRUG

Intravenous infusion of 30min duration

LPM3480392 X1mg; LPM3480392 X2mg; LPM3480392 X3mg; LPM3480392 X4mg; LPM3480392 X5mg; LPM3480392 X6mg; LPM3480392 X7mg; LPM3480392 X8mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (1)

The second affiliated hosipital zhejiang university school of medicine

Hangzhou, Zhejiang, 310000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: May 17, 2023
• Study Start: February 25, 2021
• Primary Completion: November 2, 2021
• Study Completion: November 2, 2021
• Last Updated: May 17, 2023

Record last verified: 2023-05

Locations

CN (1)