A Clinical Study Trial of Phenlarmide in China

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

1. To evaluate the tolerance and safety of FLA tablets in healthy volunteers.
2. To evaluate the pharmacokinetics of FLA tablets in healthy volunteers.
3. Provide basis for dosage setting for follow-up clinical research.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: Phenlarmide Tablets; Drug: Placebos

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100032
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FLZ-150mg experimental; 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; 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.; Other Names: FLZ
Placebo Comparator: FLZ-150mg placebo; 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; 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.; Other Names: FLZ-Placebos
Experimental: FLZ-600mg experimental; 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; 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.; Other Names: FLZ
Placebo Comparator: FLZ-600mg placebo; 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; 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.; Other Names: FLZ-Placebos
Experimental: FLZ-900mg experimental; 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; 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.; Other Names: FLZ
Placebo Comparator: FLZ-900mg placebo; 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; 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.; 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

Collaborators and Investigators

• Sponsor: Yiling Pharmaceutical Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2019
• Primary Completion (Actual): December 2, 2020
• Study Completion (Actual): December 2, 2020

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: November 12, 2019
• First Posted (Actual): November 15, 2019

Study Record Updates

• Last Update Posted (Actual): December 14, 2021
• Last Update Submitted That Met QC Criteria: December 11, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetic characteristics; Tolerance
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: FLZPD1002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No