NCT05116111

A Study To Evaluate the Safety, Tolerance, Pharmacokinetics/Pharmacodynamics and Efficacy of SYHA1402 Tablets For the Treatment of Patients With Diabetic Peripheral Neuropathy in China

A Randomized, Multi-center, Double-blind, Parallel-group, Placebo-controlled Phase II Study To Evaluate the Safety, Tolerance, Pharmacokinetics/Pharmacodynamics and Efficacy of SYHA1402 Tablets For the Treatment of Patients With Diabetic Peripheral Neuropathy in China

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the safety, tolerance, pharmacokinetics/pharmacodynamics and efficacy of SYHA1402 tablets for the treatment of patients with diabetic peripheral neuropathy (DPN) in China.

Detailed description

This is a randomized, multi-center, double-blind, parallel-group, placebo-controlled, phase II clinical trial to evaluate safety, tolerance, pharmacokinetics/pharmacodynamics and efficacy of SYHA1402 tablets in DPN patients. A total number of 135 patients will be randomized (2:2:1) into three groups. Patients between 18 and 75 years old and diagnosed with a Distal Symmetric Polyneuropathy (DSPN) prior to study enrolment will be enrolled. The study consists of 4 stages: a 2-week screening period, a 1-week placebo introduction period, a 16-week randomized double-blind treatment period, and a 2-week post-study follow-up period. The overall planned duration of this study is approximately 21 weeks.

Conditions

• Distal Symmetric Polyneuropathy (DSPN)

Interventions

Type	Name	Description
DRUG	SYHA1402 tablets	SYHA1402 tablets, oral, twice daily
DRUG	Placebo	Placebo, oral, twice daily

Timeline

• Start date: 2021-12-31
• Primary completion: 2023-05-15
• Completion: 2023-06-15
• First posted: 2021-11-10
• Last updated: 2021-11-12