Safety Study of Anti-Asthma Agent BMEC-1217B
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|ClinicalTrials.gov Identifier: NCT00425971|
Recruitment Status : Unknown
Verified September 2008 by Medigreen Biotechnology Corp..
Recruitment status was: Recruiting
First Posted : January 24, 2007
Last Update Posted : September 4, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: BMEC-1217B||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Dose-Escalating Safety Study of BMEC-1217B, in Healthy Volunteers|
|Study Start Date :||July 2008|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00425971
|Contact: Renee Ding, CRA||886-2-82596859 ext firstname.lastname@example.org|
|Tri-Service General Hospital||Recruiting|
|Taipei, Taiwan, 114|
|Contact: Renee Ding, CRA 886-82596859 ext 874 email@example.com|
|Principal Investigator: Horng-Chin Yan, M.D., Ph.D.|
|Principal Investigator:||Horng-Chin Yan, M.D., Ph.D.||Tri-Service General Hospital, Taipei, Taiwan|