A Clinical Study Trial of Phenlarmide in China

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04164121
• Other study ID #: FLZPD1002
• Status: Completed
• Phase: Phase 1
• Start date: December 17, 2019
• Est. completion date: December 2, 2020

Study information

• Verified date: December 2021
• Source: Yiling Pharmaceutical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2, 2020
• Est. primary completion date: December 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Peking union medical college hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Yiling Pharmaceutical Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerance evaluation index	maximum tolerated dose (MTD), dose limited toxicity (DLT)	From 0 to 20 days after dosing
Primary	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
Primary	Peak Plasma Concentration (Cmax)	The PK parameters of the plasma sample	From 0 to 168 hours after the first dose
Primary	t1/2	The PK parameters of the plasma sample	From 0 to 168 hours after the first dose
Primary	Vz/F	The PK parameters of the plasma sample	From 0 to 168 hours after the first dose
Primary	CL/F	The PK parameters of the plasma sample	From 0 to 168 hours after the first dose
Primary	Mean residence time (MRT) parameter	The PK parameters of the plasma sample	From 0 to 168 hours after the first dose
Primary	Kel	The PK parameters of the plasma sample	From 0 to 168 hours after the first dose
Primary	Area under the plasma concentration versus time curve (AUC0-8)	The PK parameters of the plasma sample	From 0 to 168 hours after the first dose
Primary	AUC0-24	The PK parameters of the plasma sample	From 0 to 168 hours after the first dose
Primary	AUC0-72	The PK parameters of the plasma sample	From 0 to 168 hours after the first dose
Primary	AUC0-last	The PK parameters of the plasma sample	From 0 to 168 hours after the first dose
Primary	Tmax, ss	The PK parameters of the plasma sample	From 0 to 72 hours after the last dose
Primary	Cmax, ss	The PK parameters of the plasma sample	From 0 to 72 hours after the last dose
Primary	Cmin, ss	The PK parameters of the plasma sample	From 0 to 72 hours after the last dose
Primary	Cavg, ss	The PK parameters of the plasma sample	From 0 to 72 hours after the last dose
Primary	t1/2, ss	The PK parameters of the plasma sample	From 0 to 72 hours after the last dose
Primary	AUC0-24, ss	The PK parameters of the plasma sample	From 0 to 72 hours after the last dose
Primary	AUC0-72, ss	The PK parameters of the plasma sample	From 0 to 72 hours after the last dose
Primary	AUC0-8, ss	The PK parameters of the plasma sample	From 0 to 72 hours after the last dose
Primary	AUC0-last, ss	The PK parameters of the plasma sample	From 0 to 72 hours after the last dose