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

NCT05238701 | Completed Phase 1 DMC

• 1 other identifier: LY03015/CT-CHN-101
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Huntington Disease; Tardive Dyskinesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• 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

Study Arms (2)

LPM3770164

EXPERIMENTAL

LPM3770164 sustained-release tablets will be administrated with single dose from 0.5mg to 60mg

Drug: LPM3770164 sustained release tablet

Placebo

PLACEBO COMPARATOR

LPM3770164 sustained release tablet simulant will be administrated with single dose

Drug: LPM3770164 sustained release tablet simulant

Interventions

LPM3770164 sustained release tablet DRUG

LPM3770164 sustained release tablet will be administrated orally single-dose on day 1

Also known as: LY03015

LPM3770164

LPM3770164 sustained release tablet simulant DRUG

LPM3770164 sustained release tablet simulant will be administrated orally single-dose on day 1

Also known as: LY03015 simulant

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 \~ 28.0 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, 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 14 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 or a positive urine drug screen;
• Subject who has daily smoking of ≥ 5 cigarettes;
• 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;
• Subject has used blood products or being blood donor or blood loss;

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Huntington Disease; Tardive Dyskinesia

Condition Hierarchy (Ancestors)

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

Study Officials

• hufang 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: January 9, 2022
• First Posted: February 14, 2022
• Study Start: February 25, 2022
• Primary Completion: November 4, 2023
• Study Completion: November 4, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)