Single-dose and Multiple-dose X842 Phase 1 Study

PHASE1CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

October 23, 2018

Primary Completion Date

September 4, 2019

Study Completion Date

September 4, 2019

Conditions
Healthy Volunteers
Interventions
DRUG

Single ascending dose of X842

A total of 7 dose groups will be set for the ascending dose: 5.6 mg, 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, 225 mg. In the 5.6 mg dose group, 4 subjects will receive X842; in the 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, 225 mg dose groups, 8 subjects in each group will receive X842. Each subject can only receive a certain dose level and cannot enter in multiple dose groups repeatedly.

DRUG

Multiple ascending dose of X842

Two dose groups will be set, including the groups receiving the recommended phase II dose and a higher dose; Eight subjects will be enrolled in each group, with half male and half female, who will receive X842 once daily for 5 consecutive days. Each subject can only receive a certain dose level and cannot enter in multiple dose groups repeatedly.

OTHER

Food Effect

Twelve subjects (appropriate ratio of male to female) screened for eligibility will be randomized into Group A and B. The 6 subjects in Group A will take the study drug (X842) in fasted condition and subject in Group B will take the study drug in fed condition in the 1st cycle. In the 2nd Cycle, subjects in Group A will take the study drug in fed condition, and subjects in Group B will take the study drug in fasted condition. The interval between the two cycles is at least 7 days.

Trial Locations (1)

550004

The Affiliated Hospital of Guizhou Medical University, Guiyang

All Listed Sponsors
lead

Jiangsu Sinorda Biomedicine Co., Ltd

INDUSTRY

NCT04293965 - Single-dose and Multiple-dose X842 Phase 1 Study | Biotech Hunter | Biotech Hunter