NCT03988413

Study on Safety, Absorption and Metabolism of SYHA1402 Tablets in Healthy People

Single-center, Randomized, Double-blind, Placebo-controlled, Single Dose Ascending Trial of SYHA1402 Tablets in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The trial used single-center, randomized, double-blind, placebo-controlled, single-dose study. The trial planned to enroll sixty-two healthy volunteers. The subjects were allocated to seven dose groups, including 25 mg (4+2), 50 mg (8+2), 100 mg (8+2), 200 mg (8+2), 400 mg (8+2), 800 mg (6+2) and 1200 mg (6+2). Each dose group was allocated test drugs and placebos according to the proportion of subjects in the brackets mentioned above.

Conditions

• Diabetic Neuropathy Peripheral

Interventions

Type	Name	Description
DRUG	25mg	SYHA1402 25mg or Placebo 25mg
DRUG	50mg	SYHA1402 50mg or Placebo 50mg
DRUG	100mg	SYHA1402 100mg or Placebo 100mg
DRUG	200mg	SYHA1402 200mg or Placebo 200mg
DRUG	400mg	SYHA1402 400mg or Placebo 400mg
DRUG	800mg	SYHA1402 800mg or Placebo 800mg

Timeline

• Start date: 2019-08-05
• Primary completion: 2020-01-14
• Completion: 2020-01-14
• First posted: 2019-06-17
• Last updated: 2020-04-30

Locations

1 site across 1 country: China