A Clinical Study Trial of Phenlarmide in China

Study Overview
=================
Brief Summary
-----------------
To evaluate the tolerance and safety of FLA tablets in healthy volunteers. To evaluate the pharmacokinetics of FLA tablets in healthy volunteers. Provide basis for dosage setting for follow-up clinical research.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Single-dose, Multiple-dose, Incremental Tolerance and Pharmacokinetics Study of Phenlarmide Tablets in Chinese Healthy Adult Volunteers

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Drug: Phenlarmide Tablets
* Drug: Placebos


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1)18-65 years old (including upper and lower limits); 2)Men and women are not limited; 3)Men weigh more than 50 kg, women weigh more than 45 kg, BMI 19-28 kg/m2 (including upper and lower limits); 4)Understand and sign the informed consent, understand the research process and requirements, and volunteer to participate in this study. Exclusion Criteria: 1)There is a history of heart, liver, kidney, respiratory, digestive tract, nervous system, endocrine, immune or hematological diseases judged by researchers as having clinical significance; 2)There are abnormalities in vital signs, general physical examination, laboratory examination and ECG examination, which are judged to be of clinical significance by researchers; 3)Any drug was taken within two weeks before the study was administered, and the researchers believe that this condition may affect the evaluation results of the study; 4)There is a significant history of drug allergy or hypersensitivity in food that researchers have identified as clinically significant; 5)The positive results of serological tests (HBsAg, anti-HCV, anti-HIV or TP-Ab) were found at the time of screening; 6)One year before the study was administered, some researchers believed that alcohol or drug abuse history might affect the results of this study, or that alcohol breath test or urine drug screening test were positive during screening; 7)Those who had smoking history within three months before the first administration or who had positive urinary cotinine test in screening stage; 8)Those who participated in any clinical trial within 3 months before administration; 9)Those who donated blood more than 400 mL or 2 units within 3 months before administration; 10)Do not agree to avoid the use of tobacco, alcohol or caffeine-containing beverages within 24 hours before and during the trial, or to avoid vigorous exercise, or to avoid other factors affecting drug absorption, distribution, metabolism and excretion; 11)Pregnant or lactating women, or those with positive serum HCG test before administration, or those who are unable or unwilling to adopt contraceptive measures approved by the researchers during the study period and within three months after the end of the study, as directed by the researchers; 12)Researchers do not consider it suitable for participants in this clinical study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FLZ-150mg experimental<br>Oral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 150mg each time from day 8 to day 17. | Drug: Phenlarmide Tablets<br>* Oral administration was conducted on an empty stomach, and the drug was administered once a day on day 1 and once a day from day 8 to day 17.<br>* Other names: FLZ;|
| Placebo Comparator: FLZ-150mg placebo<br>Oral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 150mg each time from day 8 to day 17. | Drug: Placebos<br>* Oral administration was conducted on an empty stomach, and the drug was administered once a day on day 1 and once a day from day 8 to day 17.<br>* Other names: FLZ-Placebos;|
| Experimental: FLZ-600mg experimental<br>Oral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 600mg each time from day 8 to day 17. | Drug: Phenlarmide Tablets<br>* Oral administration was conducted on an empty stomach, and the drug was administered once a day on day 1 and once a day from day 8 to day 17.<br>* Other names: FLZ;|
| Placebo Comparator: FLZ-600mg placebo<br>Oral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 600mg each time from day 8 to day 17. | Drug: Placebos<br>* Oral administration was conducted on an empty stomach, and the drug was administered once a day on day 1 and once a day from day 8 to day 17.<br>* Other names: FLZ-Placebos;|
| Experimental: FLZ-900mg experimental<br>Oral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 900mg each time from day 8 to day 17. | Drug: Phenlarmide Tablets<br>* Oral administration was conducted on an empty stomach, and the drug was administered once a day on day 1 and once a day from day 8 to day 17.<br>* Other names: FLZ;|
| Placebo Comparator: FLZ-900mg placebo<br>Oral administration was conducted on an empty stomach, and the drug or placebo was administered once a day on day 1 and 900mg each time from day 8 to day 17. | Drug: Placebos<br>* Oral administration was conducted on an empty stomach, and the drug was administered once a day on day 1 and once a day from day 8 to day 17.<br>* Other names: FLZ-Placebos;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance evaluation index | maximum tolerated dose (MTD), dose limited toxicity (DLT) | From 0 to 20 days after dosing | 
| Tmax | The amount of time that a drug is present at the maximum concentration in serum. | From 0 to 168 hours after the first dose | 
| Peak Plasma Concentration (Cmax) | The PK parameters of the plasma sample | From 0 to 168 hours after the first dose | 
| t1/2 | The PK parameters of the plasma sample | From 0 to 168 hours after the first dose | 
| Vz/F | The PK parameters of the plasma sample | From 0 to 168 hours after the first dose | 
| CL/F | The PK parameters of the plasma sample | From 0 to 168 hours after the first dose | 
| Mean residence time (MRT) parameter | The PK parameters of the plasma sample | From 0 to 168 hours after the first dose | 
| Kel | The PK parameters of the plasma sample | From 0 to 168 hours after the first dose | 
| Area under the plasma concentration versus time curve (AUC0-∞) | The PK parameters of the plasma sample | From 0 to 168 hours after the first dose | 
| AUC0-24 | The PK parameters of the plasma sample | From 0 to 168 hours after the first dose | 
| AUC0-72 | The PK parameters of the plasma sample | From 0 to 168 hours after the first dose | 
| AUC0-last | The PK parameters of the plasma sample | From 0 to 168 hours after the first dose | 
| Tmax, ss | The PK parameters of the plasma sample | From 0 to 72 hours after the last dose | 
| Cmax, ss | The PK parameters of the plasma sample | From 0 to 72 hours after the last dose | 
| Cmin, ss | The PK parameters of the plasma sample | From 0 to 72 hours after the last dose | 
| Cavg, ss | The PK parameters of the plasma sample | From 0 to 72 hours after the last dose | 
| t1/2, ss | The PK parameters of the plasma sample | From 0 to 72 hours after the last dose | 
| AUC0-24, ss | The PK parameters of the plasma sample | From 0 to 72 hours after the last dose | 
| AUC0-72, ss | The PK parameters of the plasma sample | From 0 to 72 hours after the last dose | 
| AUC0-∞, ss | The PK parameters of the plasma sample | From 0 to 72 hours after the last dose | 
| AUC0-last, ss | The PK parameters of the plasma sample | From 0 to 72 hours after the last dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tolerance, Safety, Pharmacokinetic characteristics