Clinical trial NCT04164121: A Clinical Study Trial of Phenlarmide in China
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson Disease
Keywords: Tolerance
Safety
Pharmacokinetic characteristics
Lead sponsor: Yiling Pharmaceutical Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-15
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


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.

Primary outcomes:
measure: Tolerance evaluation index
timeFrame: From 0 to 20 days after dosing
measure: Tmax
timeFrame: From 0 to 168 hours after the first dose
measure: Peak Plasma Concentration (Cmax)
timeFrame: From 0 to 168 hours after the first dose
measure: t1/2
timeFrame: From 0 to 168 hours after the first dose
measure: Vz/F
timeFrame: From 0 to 168 hours after the first dose
measure: CL/F
timeFrame: From 0 to 168 hours after the first dose
measure: Mean residence time (MRT) parameter
timeFrame: From 0 to 168 hours after the first dose
measure: Kel
timeFrame: From 0 to 168 hours after the first dose
measure: Area under the plasma concentration versus time curve (AUC0-∞)
timeFrame: From 0 to 168 hours after the first dose
measure: AUC0-24
timeFrame: From 0 to 168 hours after the first dose
measure: AUC0-72
timeFrame: From 0 to 168 hours after the first dose
measure: AUC0-last
timeFrame: From 0 to 168 hours after the first dose
measure: Tmax, ss
timeFrame: From 0 to 72 hours after the last dose
measure: Cmax, ss
timeFrame: From 0 to 72 hours after the last dose
measure: Cmin, ss
timeFrame: From 0 to 72 hours after the last dose
measure: Cavg, ss
timeFrame: From 0 to 72 hours after the last dose
measure: t1/2, ss
timeFrame: From 0 to 72 hours after the last dose
measure: AUC0-24, ss
timeFrame: From 0 to 72 hours after the last dose
measure: AUC0-72, ss
timeFrame: From 0 to 72 hours after the last dose
measure: AUC0-∞, ss
timeFrame: From 0 to 72 hours after the last dose
measure: AUC0-last, ss
timeFrame: From 0 to 72 hours after the last dose
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking union medical college hospital
state: Beijing
Study officials:
References: