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

NCT06216054 | Completed Phase 1 DMC

• 1 other identifier: LY03015/CT-CHN-102
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tardive Dyskinesia; Huntington Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (2)

LPM3770164

EXPERIMENTAL

LPM3770164 sustained-release tablets will be administrated with multiple doses from 5mg to 30mg on day 1\~10

Drug: LPM3770164 sustained release tablet

Placebo

PLACEBO COMPARATOR

LPM3770164 sustained release tablet simulant will be administrated on day 1\~10

Drug: LPM3770164 sustained release tablet simulant

Interventions

LPM3770164 sustained release tablet DRUG

administrated orally

LPM3770164

LPM3770164 sustained release tablet simulant DRUG

administrated orally

Placebo

Eligibility Criteria

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

You may qualify if:

• Subject who voluntarily participate and sign the informed consent form;
• Healthy male/female volunteers aged 18 to 45 years;
• 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;
• Able to comply with the lifestyle restrictions.

You may not qualify if:

• Subject has a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution;
• 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;
• 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;.
• Subject has a history of self-mutilation; or at risk of suicide;
• 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;
• Subject has abnormal vital signs, laboratory abnormalities, and ECGs;
• Subject has used any of over-the-counter products within 7 days or prescription medications within 28 days prior to dosing;
• Subject positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or syphilis seroreactivity (Trust);
• Subject has a history of alcohol abuse within 1 year or positive alcohol breath test results;
• Subject has a history of substance abuse within 1 year or a positive urine drug screen;
• Subject who has daily smoking of ≥ 5 cigarettes within 3 months;
• Subject who has special requirements for food, cannot comply with the unified diet or have dysphagia;
• Subject who has consumption of xanthine-rich foods or beverages (such as tea, coffee, cola, or chocolate) within 3 days prior to administration;
• Subject who has consumption of food or beverages containing grapefruit within 7 days prior to administration;
• Subject who has participated in other clinical trials within 3 months before administration;

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Tardive Dyskinesia; Huntington Disease

Condition Hierarchy (Ancestors)

Dyskinesia, Drug-Induced; Dyskinesias; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Basal Ganglia Diseases; Brain Diseases; Dementia; Chorea; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Huafang Li, Doctor

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 22, 2024
• Study Start: December 19, 2023
• Primary Completion: July 29, 2024
• Study Completion: July 29, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

CN (1)