NCT03458650View on ClinicalTrials.gov

A Phase I Study of LuoXin Innovate (LXI-15028) in Healthy Chinese Subjects to Evaluate the Pharmacokinetics, Safety and Tolerability.

PHASE1CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

March 19, 2018

Primary Completion Date

April 23, 2018

Study Completion Date

May 8, 2018

Conditions
Healthy
Interventions
DRUG

LXI-15028 50mg

In escalated single-dose study, the subjects in each dose group will receive single oral dose of 50 mg LXI-15028 tablet or 1 matching placebo tablet at fasted state,

DRUG

LXI-15028 100mg

100 mg LXI-15028 tablet or matching placebo 1 tablet at fasted state, In multiple-dose study, the subjects who administered 100mg single dose will continuously receive oral 100 mg LXI-15028 tablet or 1 matching placebo tablet once daily (QD) for 10 times.

DRUG

LXI-15028 200mg

single oral dose 2 100 mg LXI-15028 tablets or 2 matching placebo tablets at fasted state

DRUG

Placebo

matching placebo tablets

Trial Locations (1)

200040

Huashan Hospital, Fudan University, Shanghai

All Listed Sponsors
lead

Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.

INDUSTRY

NCT03458650 - A Phase I Study of LuoXin Innovate (LXI-15028) in Healthy Chinese Subjects to Evaluate the Pharmacokinetics, Safety and Tolerability. | Biotech Hunter | Biotech Hunter