Clinical trial NCT05238701: A Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic of LPM3770164 in Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Huntington Disease
Tardive Dyskinesia
Lead sponsor: Luye Pharma Group Ltd.
Sponsor class: INDUSTRY
First posted: 2022-02-14
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Treatment-emergent adverse effects
timeFrame: from baseline to day 28
Secondary outcomes:
measure: Maximum observed concentration (Cmax)
timeFrame: from baseline to day 15
measure: Time to maximum observed concentration (Tmax)
timeFrame: from baseline to day 15
measure: Area under the concentration-time curve (AUC)
timeFrame: from baseline to day 15
measure: Clearance (CL)
timeFrame: from baseline to day 15
measure: Half-life (t1/2)
timeFrame: from baseline to day 15
measure: Mean Residence Time (MRT)
timeFrame: from baseline to day 15
measure: Haematology
timeFrame: baseline, day 3, day 8, day 15, day 28
measure: Blood Chemistry
timeFrame: baseline, day 3, day 8, day 15, day 28
measure: Urinalysis
timeFrame: baseline, day 15, day 28
measure: Coagulation
timeFrame: baseline, day 15, day 28
measure: Body Temperature
timeFrame: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
measure: Respiratory Rate
timeFrame: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
measure: Blood Pressure
timeFrame: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
measure: Pulse Rate
timeFrame: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
measure: Physical Examination
timeFrame: baseline, day 15, day 28
measure: 12 lead electrocardiogram corrected QT interval
timeFrame: baseline, day 1, day 2, day 3, day 4, day 6, day 8, day 11, day 15, day 28
measure: Simpson-Angus Rating Scale (SAS)
timeFrame: baseline, day 3, day 28
measure: Barnes Akathisia Rating Scale (BARS)
timeFrame: baseline, day 3, day 28
measure: Abnormal Involuntary Movement Scale (AIMS)
timeFrame: baseline, day 3, day 28
measure: Stanford Sleepiness Scale (SSS)
timeFrame: baseline, day 3, day 28
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: hufang Li, Doctor
role: PRINCIPAL_INVESTIGATOR
References: