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

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

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

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-08-31

Primary Completion

2020-01-31

Completion

2020-05-31