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
  Purpose

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
Asthma
Drug: BMEC-1217B
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Dose-Escalating Safety Study of BMEC-1217B, in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Medigreen Biotechnology Corp.:

Estimated Enrollment: 32
Study Start Date: July 2008
  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425971

Contacts
Contact: Renee Ding, CRA 886-2-82596859 ext 874 renee@medigreen.com

Locations
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.         
Sponsors and Collaborators
Medigreen Biotechnology Corp.
Investigators
Principal Investigator: Horng-Chin Yan, M.D., Ph.D. Tri-Service General Hospital, Taipei, Taiwan
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00425971     History of Changes
Other Study ID Numbers: ITRI-BEL1217B-CP002
Study First Received: January 23, 2007
Last Updated: September 3, 2008
Health Authority: United States: Food and Drug Administration
Taiwan: Department of Health

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014