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Sponsored by: |
Medigreen Biotechnology Corp. |
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Information provided by: | Medigreen Biotechnology Corp. |
ClinicalTrials.gov Identifier: | NCT00425971 |
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 | Intervention | Phase |
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Asthma |
Drug: BMEC-1217B |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
Official Title: | A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Dose-Escalating Safety Study of BMEC-1217B, in Healthy Volunteers |
Ages Eligible for Study: | 20 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Renee Ding, CRA | 886-2-82596859 ext 874 | renee@medigreen.com |
Taiwan | |
Tri-Service General Hospital | Recruiting |
Taipei, Taiwan, 114 | |
Contact: Renee Ding, CRA 886-82596859 ext 874 renee@medigreen.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 |
Study ID Numbers: | ITRI-BEL1217B-CP002 |
Study First Received: | January 23, 2007 |
Last Updated: | September 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00425971 |
Health Authority: | United States: Food and Drug Administration; Taiwan: Department of Health |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Hypersensitivity, Immediate Asthma Healthy Respiratory Hypersensitivity |
Immune System Diseases Bronchial Diseases |