Phase I Clinical Trial to Evaluate the Safety of Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC) in Healthy Adults Aged 18-65 and Patients With Pulmonary Tuberculosis

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

January 17, 2023

Primary Completion Date

May 9, 2023

Study Completion Date

May 9, 2023

Conditions
Tuberculosis
Interventions
BIOLOGICAL

Recombinant Mycobacterium Tuberculosis Fusion Protein (EEC)

"1.0ml/bottle, containing 2.5μg/ml low dose, 5μg/ml medium dose, and 10μg/ml high dose of active ingredient.~Take 0.1ml and inject it into the center of the front 1/3 of the palm side of the forearm by the Montessori method Single dose administration."

Trial Locations (2)

100050

Beijing Friendship Hospital, Capital Medical University, Beijing

101149

Beijing Chest Hospital, Capital Medical University, Beijing

All Listed Sponsors
collaborator

Beijing Chest Hospital, Capital Medical University

OTHER

collaborator

Beijing Friendship Hospital

OTHER

lead

Chengdu CoenBiotech Co., Ltd

INDUSTRY