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

NCT ID: NCT05238701

Last Updated: 2024-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-25
• Study Completion Date: 2023-11-04

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

LPM3770164

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

Group Type: EXPERIMENTAL

LPM3770164 sustained release tablet

Intervention Type: DRUG

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

Placebo

LPM3770164 sustained release tablet simulant will be administrated with single dose

Group Type: PLACEBO_COMPARATOR

LPM3770164 sustained release tablet simulant

Intervention Type: DRUG

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

Interventions

LPM3770164 sustained release tablet

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

Intervention Type: DRUG

LPM3770164 sustained release tablet simulant

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

Intervention Type: DRUG

Other Intervention Names

LY03015; LY03015 simulant

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Luye Pharma Group Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

hufang Li, Doctor

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

LY03015/CT-CHN-101

Identifier Type: -

Identifier Source: org_study_id