NCT04693039

Study on the Safety, Tolerance and Pharmacokinetics of Phenlarmide Tablets

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerance and Pharmacokinetics of Phenlarmide Tablets in Patients With Parkinson's Disease in the Early and Middle Stages

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Shijiazhuang Yiling Pharmaceutical Co. Ltd · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2021-02-23
• Primary completion: 2021-10-29
• Completion: 2021-10-29
• First posted: 2021-01-05
• Last updated: 2022-01-03

Locations

1 site across 1 country: China