NCT04161547

Tolerability and Pharmacokinetics of CSPCHA115 Capsules in Chinese Healthy Volunteers

A Phase I, Ascending Multiple-dose Clinical Trial of CSPCHA115 Capsules to Evaluate the Tolerability and Pharmacokinetics in Chinese Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A randomized, single-center, double-blind, ascending multiple-dose, placebo-controlled study to evaluate the tolerability and pharmacokinetics of CSPCHA115 capsules in Chinese healthy volunteers.

Conditions

• Asthma; Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	CSPCHA115 100 mg; Matching placebo 100 mg	CSPCHA115 100 mg once daily in the fasted state for 7 days; Matching placebo 100 mg once daily in the fasted state for 7 days.
DRUG	CSPCHA115 200 mg; Matching placebo 200 mg	CSPCHA115 200 mg once daily in the fasted state for 7 days; Matching placebo 200 mg once daily in the fasted state for 7 days.
DRUG	CSPCHA115 400 mg; Matching placebo 400 mg	CSPCHA115 400 mg once daily in the fasted state for 7 days; Matching placebo 400 mg once daily in the fasted state for 7 days.
DRUG	CSPCHA115 600 mg; Matching placebo 600 mg	CSPCHA115 600 mg once daily in the fasted state for 7 days; Matching placebo 600 mg once daily in the fasted state for 7 days.

Timeline

• Start date: 2019-12-12
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2019-11-13
• Last updated: 2021-04-28

Locations

1 site across 1 country: China