NCT03255993

The Tolerability and Pharmacokinetics of Multiple Doses of SPH3127 in Chinese Healthy People

Multiple Doses Study to Evaluate the Tolerability and Pharmacokinetics of SPH3127 in Chinese Healthy People

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study was a single center, parallel, randomized, double blind, placebo-controlled phase Ib clinical trial to to evaluate the safety and tolerability and pharmacokinetics of SPH3127 tablet in healthy subjects by increasing multiple dosing

Detailed description

Three panels(100mg, 200mg, 400mg), each consisting of eight participants (The number of individual subjects in each group was not less than 1/3 of the total number).Participants begin to receive the first dose of SPH3127 100mg. Then Participants begin to receive the second dose of SPH3127 200mg,after the researchers confirmed that the 100mg dose group was safe and well tolerated.Then the third dose of SPH3127 400mg must wait for the result of the second dose's safety and tolerability. If the subjects during escalating dose to the biggest tolerate dose group were not well tolerated, the study must adjust the maximum dose group and fall to a low dose group to conduct another test.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	SPH3127 50mg	SPH3127 50mg
DRUG	SPH3127 100mg	SPH3127 100mg
DRUG	Placebo matching to SPH3127 50mg	Placebo matching to SPH3127 50mg
DRUG	Placebo matching to SPH3127 100mg	Placebo matching to SPH3127 100mg

Timeline

• Start date: 2017-10-23
• Primary completion: 2018-09-20
• Completion: 2018-09-20
• First posted: 2017-08-21
• Last updated: 2021-11-15

Locations

1 site across 1 country: China