NCT04036656

Phase I Study of Direct Coagulation Factor Xa Inhibitor SYHA136 Tablets in Chinese Healthy Volunteers

Single-center, Randomized, Double-blind, Placebo-controlled, Single Dose Ascending Trial of SYHA 136 Tablets in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The trial used single-center, randomized, double-blind, placebo-controlled, single-dose ascending study. The trial planned to enroll fifty-six healthy volunteers. The subjects were allocated to eight dose groups, including 0.5 mg (3+1), 1 mg (3+1), 2.5 mg (6+2), 5 mg (6+2), 10 mg (6+2), 20 mg (6+2), 35 mg(6+2) and 50 mg (6+2). Each dose group was allocated test drugs and placebos according to the proportion of subjects in the brackets mentioned above.

Conditions

• Venous Thrombosis

Interventions

Type	Name	Description
DRUG	SYHA136 0.5 mg	oral tablet
DRUG	SYHA136 1 mg	oral tablet
DRUG	SYHA136 2.5 mg	oral tablet
DRUG	SYHA136 5 mg	oral tablet
DRUG	SYHA136 10 mg	oral tablet
DRUG	SYHA136 20 mg	oral tablet
DRUG	SYHA136 35 mg	oral tablet
DRUG	SYHA136 50 mg	oral tablet
DRUG	Placebo matching SYHA136 0.5 mg	oral tablet
DRUG	Placebo matching SYHA136 1 mg	oral tablet
DRUG	Placebo matching SYHA136 2.5 mg	oral tablet
DRUG	Placebo matching SYHA136 5 mg	oral tablet
DRUG	Placebo matching SYHA136 10 mg	oral tablet
DRUG	Placebo matching SYHA136 20 mg	oral tablet
DRUG	Placebo matching SYHA136 35 mg	oral tablet
DRUG	Placebo matching SYHA136 50 mg	oral tablet

Timeline

• Start date: 2019-08-01
• Primary completion: 2020-01-01
• Completion: 2020-05-01
• First posted: 2019-07-30
• Last updated: 2019-07-30