Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01999231 | Phase I Clinical Human Tolerability Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 | PHASE1 | COMPLETED | 32 | — | — | Sep 1, 2013 | Dec 1, 2013 | Mar 31, 2015 | - | — |
The main examination items :vital signs (breathing, heart rate, blood pressure, body temperature ) of each volunteer at 15min, 30min, 1h, 2h, 4h, 8h, 24h, 48h, 72h, 96h after injection, skin reactivity (redness and/or induration) of injection sites,local reaction ( rash, pain, itching, and skin mucous membranes ) ,a variety of adverse events,routine blood,routine urine, liver and kidney function, ECG and chest X-ray films before and 7 days after intradermal injection .
| Arm | Type | Description |
|---|---|---|
| 1μg/ml ESAT6-CFP10 | EXPERIMENTAL | The 1μg/ml ESAT6-CFP10 is given 0.1ml alone to volunteers in the RIGHT or LEFT forearm according to a randomisation scheme. |
| 5μg/ml ESAT6-CFP10 | EXPERIMENTAL | The 5μg/ml ESAT6-CFP10 is given 0.1ml alone to volunteers in the RIGHT or LEFT forearm according to a randomisation scheme. |
| 10μg/ml ESAT6-CFP10 | EXPERIMENTAL | The 10μg/ml ESAT6-CFP10 is given 0.1ml alone to volunteers in the RIGHT or LEFT forearm according to a randomisation scheme. |
| 20μg/ml ESAT6-CFP10 | EXPERIMENTAL | The 20μg/ml ESAT6-CFP10 is given 0.1ml alone to volunteers in the RIGHT or LEFT forearm according to a randomisation scheme. |
| Name | Type | Description |
|---|---|---|
| ESAT6-CFP10 | BIOLOGICAL | 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 . |
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 parti...