Ignite Creation Date:
2024-05-06 @ 2:14 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT01999231
Status:
COMPLETED
Last Update Posted:
2015-03-31
First Post:
2013-11-04
Brief Title:
Phase I Clinical Human Tolerability Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10
Sponsor:
Anhui Zhifei Longcom Biologic Pharmacy Co Ltd
Organization:
Anhui Zhifei Longcom Biologic Pharmacy Co Ltd
Study Overview
Official Title:
Phase I Clinical Human Tolerability Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 10μgmL maximum tolerated dose 20μgmL 6 persondose 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 andor induration diameter of injection siteslocal reaction rash pain itching and skin and mucous membranes a variety of adverse eventsroutine bloodroutine 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
24 healthy adults were included as study objects they were randomly divided into four groups of different Recombinant Allergen EC dose 1 5 10μgmL maximum tolerated dose 20μgmL 6 persondose 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 andor induration diameter of injection siteslocal reaction rash pain itching and skin and mucous membranes a variety of adverse eventsroutine bloodroutine 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
Detailed Description:
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 10μgmL maximum tolerated dose 20μgmL 6 persondose 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 01ml 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 andor induration diameter of injection siteslocal reaction rash pain itching and skin and mucous membranes a variety of adverse eventsroutine bloodroutine 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 volunteers injection in a former lower dose group
Statistical analysis is performed using SAS93 software and all analytic process is routinization
24 healthy adults were included as study objects they were randomly divided into four groups of different Recombinant EC Allergen dose 1 5 10μgmL maximum tolerated dose 20μgmL 6 persondose 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 01ml 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 andor induration diameter of injection siteslocal reaction rash pain itching and skin and mucous membranes a variety of adverse eventsroutine bloodroutine 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 volunteers injection in a former lower dose group
Statistical analysis is performed using SAS93 software and all analytic process is routinization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| LTao | REGISTRY | AnhuiZhifei | None |