NCT03128138

Single Ascending Dose Study of Safety and Tolerability of SPH3127 Tablet in Chinese Healthy Volunteers

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Describe Pharmacokinetics/Pharmacodynamics, and the Safety and of SPH3127 Tablet in Chinese Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

1. To evaluate safety, tolerability and pharmacokinetics (PK) and pharmacodynamics (PD) characteristics of SPH3127 dose escalation, a single oral dose in Chines healthy volunteers. 2. To explore the appropriate dose and provide the basis for the subsequent clinical trials.

Detailed description

48 healthy volunteers will participate in this trial. Participants will be divided into 6 group, 25mg，50mg，100mg，200mg，400mg and 800mg. In each group, 6 participants will take SPH3127 tablet, while 2 participants will take placebo randomly. Safety data and PK/PD data will be collected as protocol described.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	SPH3127	Drug: SPH3127 Tablet Drug: Placebo Tablet

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-06-30
• Completion: 2018-07-30
• First posted: 2017-04-25
• Last updated: 2022-10-27

Locations

1 site across 1 country: China