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

This is an interventional diagnostic trial for Healthy focused on measuring Safety, Tolerability, ESAT6, CFP10, skin test, diagnostic test Read More

Inclusion Criteria:

• Aged from 18 to 40 years old, age difference is not more than 10 years old within the same batch of healthy volunteers, the male to female ratio of cases is 1:1. Body mass index should be in the range of 20 to 27 Body Mass Index BMI: weight (Kg)/ height (M2);
• Agreed to participate in the test and sign the informed consent;
• Subjects should comply with the requirements of the clinical trial protocol and be followed;
• Subjects have no history of TB (Tuberculosis)or family history of tuberculosis;
• People have no pulmonary tuberculosis or extrapulmonary tuberculosis,respiratory symptom or systemic symptoms;
• People have no tuberculosis focus after examination by X-ray chest radiograph and sputum bacilli;
• Subjects have no acute or chronic disease, acute infectious diseases, dermatoses or skin allergy caused by various reasons;
• Physical condition: have no history of heart, liver, kidney, gastrointestinal tract, nervous system, or metabolic disturbance, etc. ECG, blood pressure, heart rate, respiratory status and lab test indexes including blood, urine, liver and kidney function, etc are all normal within 4 weeks before screening;
• No close contacts of tuberculosis;
• Subjects have not participated in other clinical drug trials or inoculated against other prophylactic and immune globulin in the nearly 3 months;
• Temperature is normal;
• Stop smoking, drinking and drinking contains caffeinated.

Exclusion Criteria:

• Health people have close contacts of TB (Tuberculosis)patients, especially excreter in 3 weeks before selection;
• Suffering from any other serious disease, e.g. during cancer treatment, autoimmune disease, progressive atherosclerosis, diabetes accompanied with complications, chronic obstructive pulmonary disease (COPD) needing oxygen therapy, acute or progressive liver or kidney disease, congestive heart failure, etc.;
• People have history of allergy, convulsions, epilepsy, cerebropathy, neurological symptoms and signs;
• Patients who have impaired or abnormal immune function, e.g. patients treated with immunosuppressor or immunopotentiator, received immunoglobulin preparation or blood products or plasma extraction outside the gastrointestinal tract in 3 months, human immunodeficiency virus or related diseases;
• Acute febrile illness and infection;
• Taking part in other clinic trials;
• Subjects have participated in any other clinical drug trials in 3 months before our clinical tests;
• Allergic constitution, e.g. patients have allergic history to two or more kinds of drugs or food, or drug components;
• Substance abuse and alcoholics ;
• Pregnant or breast feeding women;
• Mental or physical disability;
• Informed leavers;
• Any other cases that may influence the test evaluation.