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A Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic of LPM3770164 in Healthy Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT05238701•Luye Pharma Group Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

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;
+8 more criteria

Locations (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

February 25, 2022

Primary Completion Date

November 4, 2023

Completion Date

November 4, 2023

Last Updated

January 29, 2024

Enrollment

104

ACTUAL participants

Conditions

Huntington DiseaseTardive Dyskinesia

Interventions

LPM3770164 sustained release tablet

DRUG

LPM3770164 sustained release tablet simulant

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Study of BDNF Pathway Biomarkers in the Cerebrospinal Fluid in Patients With Huntington's Disease

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