Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00425971
Status:
UNKNOWN
Last Update Posted:
2008-09-04
First Post:
2007-01-23
Brief Title:
Safety Study of Anti-Asthma Agent BMEC-1217B
Sponsor:
Medigreen Biotechnology Corp
Organization:
Medigreen Biotechnology Corp
Study Overview
Official Title:
A Phase 1 Double-Blind Randomized Placebo-Controlled Dose-Escalating Safety Study of BMEC-1217B in Healthy Volunteers
Status:
UNKNOWN
Status Verified Date:
2008-09
Last Known Status:
RECRUITING
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:
BMEC-1217B is an abbreviated version of an old Chinese formulation The ratio of each component was adopted by the sponsor following the observation that BMEC-1217B prepared from this ratio resulted in best pharmacological profile and in vitro bioactivities
BMEC-1217B was studied for the pharmacological activity on the release of cysteinyl leukotrienes IL-4 and TNF-alpha in vitro and the airway hyperreactivity The result indicated that BMEC-1217B can inhibit the synthesis of several key pro-inflammatory mediators involved in the pathophysiology of allergic asthma and can also improve lung function in a mouse model of allergic asthma
The purpose of this study is to evaluate the safety and tolerability of increasing dose of BMEC-1217B when administered orally in healthy volunteers
BMEC-1217B was studied for the pharmacological activity on the release of cysteinyl leukotrienes IL-4 and TNF-alpha in vitro and the airway hyperreactivity The result indicated that BMEC-1217B can inhibit the synthesis of several key pro-inflammatory mediators involved in the pathophysiology of allergic asthma and can also improve lung function in a mouse model of allergic asthma
The purpose of this study is to evaluate the safety and tolerability of increasing dose of BMEC-1217B when administered orally in healthy volunteers
Detailed Description:
None
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