Safety, Tolerability and Pharmacokinetic of Multiple-ascending Doses of LPM3770164 in Healthy Subjects

A Randomized, Double-blind, Placebo-controlled, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic of Multiple-ascending Doses of LPM3770164 Sustained-release Tablets in Healthy Subjects

This is a single-center, randomized, double-blind, placebo-controlled, multiple-ascending doses 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 later clinical trials.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Huafang Li, doctor; Phone Number: +8618017311256; Email: lhlh_5@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Mental Health Center
      • Principal Investigator: Huafang Li, Doctor
      • Principal Investigator: Yimin Yu, Doctor
      • Contact: Huafang Li, doctor; Phone Number: +8618017311256; Email: lhlh_5@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 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 ~ 26.0 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/ psychology, 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 7 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 within 1 year or a positive urine drug screen;
11. Subject who has daily smoking of ≥ 5 cigarettes within 3 months;
12. Subject who has special requirements for food, cannot comply with the unified diet or have dysphagia;
13. Subject who has consumption of xanthine-rich foods or beverages (such as tea, coffee, cola, or chocolate) within 3 days prior to administration;
14. Subject who has consumption of food or beverages containing grapefruit within 7 days prior to administration;
15. Subject who has participated in other clinical trials within 3 months before administration;
16. Subject has used blood products or being blood donor or blood loss within 3 months;
17. Pregnant, lactating women, or positive pregnancy test;
18. Subject who refusal to contraception, or plan to donate sperm or ovums;
19. 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 multiple doses from 5mg to 30mg on day 1~10	Drug: LPM3770164 sustained release tablet; administrated orally
Placebo Comparator: Placebo; LPM3770164 sustained release tablet simulant will be administrated on day 1~10	Drug: LPM3770164 sustained release tablet simulant; administrated orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-emergent adverse event	Number of participants with treatment-emergent adverse event will be summarized by Group, System Organ Classification (SOC), Preferred Term (PT), severity and the relationship with treatment.	from baseline to day 37

Secondary Outcome Measures

Outcome Measure	Time Frame
Peak Plasma Concentration (Cmax)	from day 1 to day 24
Area Under the Curve from time 0 to 24 hours (AUC0-24)	from day 1 to day 24
Area Under the Curve from time 0 to the last measurable concentration (AUC0-t)	from day 1 to day 24
Area Under the Curve from time 0 extrapolated to infinity (AUC0-inf)	from day 1 to day 24
Time to maximum concentration (Tmax)	from day 1 to day 24
Half-life (t1/2)	from day 1 to day 24
ECG QTc Interval	from baseline to day 37

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2023
• Primary Completion (Estimated): August 14, 2024
• Study Completion (Estimated): August 14, 2024

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 10, 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-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No