Healthy Clinical Trial
Official title:
Phase I Clinical Human Tolerability Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10
In the tests, small sample of clinical study about Recombinant Mycobacterium Tuberculosis
Allergen ESAT6-CFP10 ( Recombination EC Allergen） healthy adults was carried out.
24 healthy adults were included as study objects, they were randomly divided into four
groups of different Recombinant Allergen EC dose (1, 5, 10μg/mL, maximum tolerated dose
20μg/mL, 6 person/dose) for single arm intradermal injection.
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) diameter of injection sites,local
reaction ( rash, pain, itching, and skin and 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 .
Preliminary evaluation of safety and tolerability of Recombinant Allergen EC applied in
humans, which can provide a safe dosage range for phase II clinical study.
This clinical study adopts an open, randomized study methods to carry out Recombinant EC
Allergen on small sample of healthy adults.
24 healthy adults were included as study objects, they were randomly divided into four
groups of different Recombinant EC Allergen dose (1, 5, 10μg/mL, maximum tolerated dose
20μg/mL, 6 person/dose) for single arm intradermal injection, and set up two people as
replacement for each group (one male and one female).
Intradermal injection into one third site of healthy subjects' left or right forearm
palmaris with 0.1ml Recombinant EC Allergen for only one time.
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) diameter of injection sites,local
reaction ( rash, pain, itching, and skin and 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 .
In phaseⅠclinical study, each person can accept only one dose, After injection of the same
dose of a volunteer group, be sure the next injection of a volunteer at 40 minutes interval.
Different dose groups: the next dose test should be carried on in the case of no serious
adverse events appear in 7days after the last one volunteer's injection in a former lower
dose group.
Statistical analysis is performed using SAS9.3 software, and all analytic process is
routinization.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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