A Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic of LPM3770164 in Healthy Subjects

A Randomized, Double-blinded, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic of LPM3770164 Sustained-release Tablets in Healthy Subjects

This is a single-center, randomized, double-blinded, placebo-controlled, dose escalation trial to evaluate the safety, tolerability and pharmacokinetic of LPM3770164 sustained-release tablets orally administered in healthy subjects under fasting state, providing the rationale information for subsequent clinical trials.

Study Overview

• Status: Completed
• Conditions: Tardive Dyskinesia; Huntington Disease
• Intervention / Treatment: Drug: LPM3770164 sustained release tablet; Drug: LPM3770164 sustained release tablet simulant

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Subject who voluntarily participate and sign the informed consent form;
2. Healthy male/female volunteers aged 18 to 45 years;
3. Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) 18.5 ~ 28.0 kg/m2, inclusive;
4. Able to comply with the lifestyle restrictions.

Exclusion Criteria:

1. Subject has a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution;
2. Subject has a current or past medical history that may affect the clinical trial or dysfunction, including but not limited to the past or current respiratory system, circulatory system, digestive system, urinary system, reproductive system, nervous system, endocrine system, immune system, motor system, blood system, psychiatry, dermatology and other clinically serious diseases or chronic diseases; or any other diseases that may interfere with the test results;
3. Any surgical condition or condition may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects;.
4. Subject has a history of self-mutilation; or at risk of suicide;
5. Subject has a history of surgery within 3 months prior to administration, or failure to recover from surgery, or having an expected surgical plan during the trial;
6. Subject has abnormal vital signs, laboratory abnormalities, and ECGs;
7. Subject has used any of over-the-counter products within 14 days or prescription medications within 28 days prior to dosing;
8. Subject positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or syphilis seroreactivity (Trust);
9. Subject has a history of alcohol abuse within 1 year or positive alcohol breath test results;
10. Subject has a history of substance abuse or a positive urine drug screen;
11. Subject who has daily smoking of ≥ 5 cigarettes;
12. Subject who has consumption of xanthine-rich foods or beverages (such as tea, coffee, cola, or chocolate) within 3 days prior to administration;
13. Subject who has consumption of food or beverages containing grapefruit within 7 days prior to administration;
14. Subject who has participated in other clinical trials within 3 months before administration;
15. Subject has used blood products or being blood donor or blood loss;
16. Pregnant, lactating women, or positive pregnancy test;
17. Subject who refusal to contraception, or plan to donate sperm or ovums;
18. Other conditions which would make participation in the study unsuitable.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LPM3770164; LPM3770164 sustained-release tablets will be administrated with single dose from 0.5mg to 60mg	Drug: LPM3770164 sustained release tablet; LPM3770164 sustained release tablet will be administrated orally single-dose on day 1; Other Names: LY03015
Placebo Comparator: Placebo; LPM3770164 sustained release tablet simulant will be administrated with single dose	Drug: LPM3770164 sustained release tablet simulant; LPM3770164 sustained release tablet simulant will be administrated orally single-dose on day 1; Other Names: LY03015 simulant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-emergent adverse effects	Number of participants with treatment-emergent adverse effects will be summarized by Group, System Organ Classification (SOC), Preferred Term (PT), severity and the relationship with treatment.	from baseline to day 28

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum observed concentration (Cmax)	from baseline to day 15
Time to maximum observed concentration (Tmax)	from baseline to day 15
Area under the concentration-time curve (AUC)	from baseline to day 15
Clearance (CL)	from baseline to day 15
Half-life (t1/2)	from baseline to day 15
Mean Residence Time (MRT)	from baseline to day 15
Haematology	baseline, day 3, day 8, day 15, day 28
Blood Chemistry	baseline, day 3, day 8, day 15, day 28
Urinalysis	baseline, day 15, day 28
Coagulation	baseline, day 15, day 28
Body Temperature	baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Respiratory Rate	baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Blood Pressure	baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Pulse Rate	baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Physical Examination	baseline, day 15, day 28
12 lead electrocardiogram corrected QT interval	baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
Simpson-Angus Rating Scale (SAS)	baseline, day 3, day 28
Barnes Akathisia Rating Scale (BARS)	baseline, day 3, day 28
Abnormal Involuntary Movement Scale (AIMS)	baseline, day 3, day 28
Stanford Sleepiness Scale (SSS)	baseline, day 3, day 28

Collaborators and Investigators

• Sponsor: Luye Pharma Group Ltd.
• Investigators: Principal Investigator: Hufang Li, Doctor, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2022
• Primary Completion (Actual): November 4, 2023
• Study Completion (Actual): November 4, 2023

Study Registration Dates

• First Submitted: January 9, 2022
• First Submitted That Met QC Criteria: February 3, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Actual): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurocognitive Disorders; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Heredodegenerative Disorders, Nervous System; Dementia; Cognition Disorders; Dyskinesia, Drug-Induced; Chorea; Dyskinesias; Tardive Dyskinesia; Huntington Disease
• Other Study ID Numbers: LY03015/CT-CHN-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No