Study on the Safety, Tolerance and Pharmacokinetics of Phenlarmide Tablets

NCT ID: NCT04693039

Last Updated: 2022-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-23
• Study Completion Date: 2021-10-29

Brief Summary

1. To evaluate the safety and tolerability of Phenlarmide tablets in patients with Parkinson's disease in the early and middle stages.

2. To evaluate the pharmacokinetics of Phenlarmide tablets in patients with Parkinson's disease.

3. To explore the efficacy of Phenlarmide tablets in the treatment of early and mid-term Parkinson's disease.

Detailed Description

1. Objective to evaluate the tolerance and safety of multiple administration of fenloramide tablets in patients with early and mid-term Parkinson's disease: To evaluate the adverse events of DLT and MTD, adverse reactions, clinical laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, stool routine), vital signs, 12 lead ECG and physical examination of fenloramide tablets in patients with early and mid-term Parkinson's disease .

2. Objective to evaluate the pharmacokinetics of fenloramide tablets in patients with Parkinson's disease in early and middle stages. The main PK parameters included Tmax, SS, Cmax, SS, cavg, SS, Ke, T1 / 2, Cl / F (only fenloramide prototype), VZ / F (only fenloramide prototype), auc0-24, SS, aucinf, SS, auc0 last, SS, AUC_ %Extrap, DF, etc.

3. Objective to explore the efficacy of fenloramide tablets in the treatment of early and mid-term Parkinson's disease, and to observe the changes of UPDRS and CGI.

Conditions

Parkinson Disease

Study Design

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

Study Groups

FLZ-150mg

Drug：Phenlarmide；Dosage：150mg；

Group Type: EXPERIMENTAL

Phenlarmide

Intervention Type: DRUG

Dosage form：Tablet; Give the medicine once a day，4 weeks is a cycle of administration, a total of 3 cycles of administration.

FLZ-300mg

Drug：Phenlarmide；Dosage：300mg；

Group Type: EXPERIMENTAL

Phenlarmide

Intervention Type: DRUG

Dosage form：Tablet; Give the medicine once a day，4 weeks is a cycle of administration, a total of 3 cycles of administration.

FLZ-600mg

Drug：Phenlarmide；Dosage：600mg；

Group Type: EXPERIMENTAL

Phenlarmide

Intervention Type: DRUG

Dosage form：Tablet; Give the medicine once a day，4 weeks is a cycle of administration, a total of 3 cycles of administration.

FLZ-900mg

Drug：Phenlarmide；Dosage：900mg；

Group Type: EXPERIMENTAL

Phenlarmide

Intervention Type: DRUG

Dosage form：Tablet; Give the medicine once a day，4 weeks is a cycle of administration, a total of 3 cycles of administration.

Placebo-150mg

Drug：Placebo；Dosage：150mg；

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Dosage form：Tablet; Give the medicine once a day，4 weeks is a cycle of administration, a total of 3 cycles of administration.

Placebo-300mg

Drug：Placebo；Dosage：300mg；

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Dosage form：Tablet; Give the medicine once a day，4 weeks is a cycle of administration, a total of 3 cycles of administration.

Placebo-600mg

Drug：Placebo；Dosage：600mg；

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Dosage form：Tablet; Give the medicine once a day，4 weeks is a cycle of administration, a total of 3 cycles of administration.

Placebo-900mg

Drug：Placebo；Dosage：900mg；

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Dosage form：Tablet; Give the medicine once a day，4 weeks is a cycle of administration, a total of 3 cycles of administration.

Interventions

Phenlarmide

Dosage form：Tablet; Give the medicine once a day，4 weeks is a cycle of administration, a total of 3 cycles of administration.

Intervention Type: DRUG

Placebo

Dosage form：Tablet; Give the medicine once a day，4 weeks is a cycle of administration, a total of 3 cycles of administration.

Intervention Type: DRUG

Other Intervention Names

FLZ-150mg; FLZ-300mg; FLZ-600mg; FLZ-900mg; Placebo-150mg; Placebo-300mg; Placebo-600mg; Placebo-900mg

Eligibility Criteria

Inclusion Criteria

1. Understand and sign the informed consent, understand the research process and requirements, and volunteer to participate in the study;

2. over 30 years old and have no gender limit;

3. Patients diagnosed with Parkinson's disease according to the Chinese diagnostic criteria for Parkinson's disease (2016 Edition);

4. Hoehn-Yahr grade ≤ 3;

5. The Unified Parkinson's disease scale (UPDRS) motor score (Part III) ≥ 10;

6. Not using anti Parkinson's disease drugs within 28 days before enrollment;

7. If the subjects are receiving dopamine receptor agonists (such as Pramipexole, etc.), anticholinergic drugs (such as Benzhexol Hydrochloride, etc.), monoamine oxidase B (MAO-B) inhibitors (such as Selegiline, Rasagiline, etc.), and N-methyl-D-aspartate (NMDA) receptor antagonists (such as Amantadine), they should stop using the drugs 28 days before the screening period;

8. Patients who had been treated with levodopa preparation (including levodopa compound preparation) for less than 6 months before screening, and had not received levodopa preparation treatment within 28 days before screening period.

Exclusion Criteria

1. Atypical Parkinson's symptoms due to the use of drugs (such as Flunarizine, Metoclopramide), nervous system diseases, genetic metabolic diseases, encephalitis, cerebrovascular diseases or other degenerative diseases (such as progressive supranuclear paralysis);

2. Patients with dementia, active mental illness or hallucination, severe depression (Beck Depression Scale - Ⅱ ≥ 29 points at screening), or Mini-Mental State Examination (MMSE) < 25 points;

3. Those who have received neurosurgical operation or electrical stimulation (such as pallidotomy, thalamotomy, deep brain electrical stimulation, etc.);

4. Patients with clinically significant abnormal liver function were defined as total bilirubin > 1.5 times of the upper limit of normal value or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times of the upper limit of normal value;

5. Patients with clinically significant renal dysfunction: creatinine clearance rate (CCR) < 30 ml / min (using Cockcroft-Gault formula);

6. Patients with uncontrollable or severe cardiovascular diseases, including NYHA grade II or above congestive heart failure, unstable angina pectoris, myocardial infarction, arrhythmia requiring treatment at the time of screening, and QTc interval prolongation more than 480ms, in 6 months before the first administration of trial drug;

7. There is a history of heart, liver, kidney, respiratory, digestive, endocrine, immune or blood system diseases considered by researchers to be serious;

8. During the screening period, the patients with HIV positive, HBV or HCV infection and syphilis infection were active;

9. Patients with malignant tumor within 5 years before screening were excluded from cervical carcinoma in situ, skin basal cell or squamous cell carcinoma, local prostate cancer after radical operation and breast intraductal carcinoma in situ after radical operation;

10. There were significant food or drug allergy history or hypersensitivity reaction judged by researchers as having clinical significance;

11. Participants in any clinical trials within 3 months before administration of the study;

12. Pregnant or lactating women, or those whose serum hCG test is positive before trial administration, who are unable or unwilling to take contraceptive measures approved by the researcher during the study period and within 3 months after the end of the study according to the instructions of the researcher;

13. Those considered unsuitable by the researchers to participate in this clinical trial.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: collaborator

Shijiazhuang Yiling Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

biao chen

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

Chen Biao

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

FLZPD1003

Identifier Type: -

Identifier Source: org_study_id