Phase I Clinical Human Tolerability Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

October 31, 2013

Study Completion Date

December 31, 2013

Conditions
Healthy
Interventions
BIOLOGICAL

ESAT6-CFP10

32 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects(three male and three female) , at the same time set up two people for substitute (one male and one female) . ESAT6-CFP10 administered intradermally by the mantoux injection technique. Each receives only one dosage in right or left arm .

All Listed Sponsors
collaborator

Shanghai Public Health Clinical Center

OTHER_GOV

collaborator

Air Force Military Medical University, China

OTHER

collaborator

Proswell Medical Corporation

INDUSTRY

lead

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

INDUSTRY

NCT01999231 - Phase I Clinical Human Tolerability Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 | Biotech Hunter | Biotech Hunter