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Safety Study of Anti-Asthma Agent BMEC-1217B

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Medigreen Biotechnology Corp..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medigreen Biotechnology Corp.
ClinicalTrials.gov Identifier:
NCT00425971
First received: January 23, 2007
Last updated: September 3, 2008
Last verified: September 2008

January 23, 2007
September 3, 2008
July 2008
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Complete list of historical versions of study NCT00425971 on ClinicalTrials.gov Archive Site
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Safety Study of Anti-Asthma Agent BMEC-1217B
A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Dose-Escalating Safety Study of BMEC-1217B, in Healthy Volunteers

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.

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Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Asthma
Drug: BMEC-1217B
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
32
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Inclusion Criteria:

  1. Nonsmoking healthy adults between 20 and 40 years old.
  2. Determined to be in good health based on medical history, clinical laboratory test values within normal range. Body weight within 20% of the ideal body weight [(height - 80) x 0.7].
  3. No recent history of drug or alcohol abuse within one year prior to study enrollment
  4. Signed informed consent form.

Exclusion Criteria:

  1. Has any condition that interferes with the ability of the subject to comply with the requirements of the study.
  2. Has known allergy to the study drug.
  3. Has an acute illness or surgery within 28 days prior to study enrollment
  4. Has participated in other investigational trials within 28 days prior to study enrollment.
  5. Has taken prescription medication and/or over-the-counter medication*4 and/or botanical medications within 28 days prior to study enrollment.
  6. Has alcohol and caffeine consumption within 24 hours prior to the administration of study drug.
  7. Has evidence of significant renal, cardiovascular, hepatic, hematopoetic, neurological, pulmonary or gastrointestinal pathology, or any other medical reason or disease that might interfere with the study objectives, as determined by the investigator.
  8. Has donation or receive of more than 450 mL of blood within 28 days prior to the study enrollment.
  9. Female subjects of child bearing potential who are pregnant, nursing, do not agree to practice effective birth control during the time period from 14 days before administration of study drug to 28 days after administration of study drug, or with irregular or abnormal menstruation.
  10. Clinically significant deviation from normal physical examination findings that, in the principal investigator's judgment, may interfere with the study evaluation or affect subject safety.
  11. Test positive for HIV, HBV or HCV
  12. Test results indicate liver function failure
  13. Has been diagnosed with Diabetes Mellitus
Both
20 Years to 40 Years
Yes
Contact: Renee Ding, CRA 886-2-82596859 ext 874 renee@medigreen.com
Taiwan
 
NCT00425971
ITRI-BEL1217B-CP002
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Medigreen Biotechnology Corp.
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Principal Investigator: Horng-Chin Yan, M.D., Ph.D. Tri-Service General Hospital, Taipei, Taiwan
Medigreen Biotechnology Corp.
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP