A Clinical Study Trial of Phenlarmide in China

NCT ID: NCT04164121

Last Updated: 2021-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-17
• Study Completion Date: 2020-12-02

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.

Conditions

Parkinson Disease

Keywords

Tolerance; Safety; Pharmacokinetic characteristics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Phenlarmide Tablets

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Phenlarmide Tablets

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Phenlarmide Tablets

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

FLZ; FLZ-Placebos

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yiling Pharmaceutical Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking union medical college hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

FLZPD1002

Identifier Type: -

Identifier Source: org_study_id