A Clinical Study Trial of Phenlarmide in China

NCT04164121 | Completed Phase 1

• 1 other identifier: FLZPD1002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson Disease

Keywords

Tolerance; Safety; Pharmacokinetic characteristics

Outcome Measures

Primary Outcomes (21)

• 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

Study Arms (6)

FLZ-150mg experimental

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

FLZ-150mg placebo

PLACEBO COMPARATOR

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

FLZ-600mg experimental

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

FLZ-600mg placebo

PLACEBO COMPARATOR

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

FLZ-900mg experimental

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

FLZ-900mg placebo

PLACEBO COMPARATOR

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

Interventions

Phenlarmide Tablets 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.

Also known as: FLZ

FLZ-150mg experimental; FLZ-600mg experimental; FLZ-900mg experimental

Placebos 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.

Also known as: FLZ-Placebos

FLZ-150mg placebo; FLZ-600mg placebo; FLZ-900mg placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• )18-65 years old (including upper and lower limits);
• )Men and women are not limited;
• )Men weigh more than 50 kg, women weigh more than 45 kg, BMI 19-28 kg/m2 (including upper and lower limits);
• )Understand and sign the informed consent, understand the research process and requirements, and volunteer to participate in this study.

You may not qualify if:

• )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;
• )There are abnormalities in vital signs, general physical examination, laboratory examination and ECG examination, which are judged to be of clinical significance by researchers;
• )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;
• )There is a significant history of drug allergy or hypersensitivity in food that researchers have identified as clinically significant;
• )The positive results of serological tests (HBsAg, anti-HCV, anti-HIV or TP-Ab) were found at the time of screening;
• )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;
• )Those who had smoking history within three months before the first administration or who had positive urinary cotinine test in screening stage;
• )Those who participated in any clinical trial within 3 months before administration;
• )Those who donated blood more than 400 mL or 2 units within 3 months before administration;
• )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;
• )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;
• )Researchers do not consider it suitable for participants in this clinical study.

Sponsors & Collaborators

• Yiling Pharmaceutical Inc.: lead

Study Sites (1)

Peking union medical college hospital

Beijing, Beijing Municipality, 100032, China

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 15, 2019
• Study Start: December 17, 2019
• Primary Completion: December 2, 2020
• Study Completion: December 2, 2020
• Last Updated: December 14, 2021

Record last verified: 2021-12

Locations

CN (1)