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.

Study Overview

• Status: Unknown
• Conditions: Asthma
• Intervention / Treatment: Drug: BMEC-1217B

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 114
    • Recruiting
    • Tri-Service General Hospital
    • Contact: Renee Ding, CRA; Phone Number: 874 886-82596859; Email: renee@medigreen.com
    • Principal Investigator: Horng-Chin Yan, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Collaborators and Investigators

• Sponsor: Medigreen Biotechnology Corp.
• Investigators: Principal Investigator: Horng-Chin Yan, M.D., Ph.D., Tri-Service General Hospital, Taipei, Taiwan

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: January 23, 2007
• First Submitted That Met QC Criteria: January 23, 2007
• First Posted (Estimate): January 24, 2007

Study Record Updates

• Last Update Posted (Estimate): September 4, 2008
• Last Update Submitted That Met QC Criteria: September 3, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: ITRI-BEL1217B-CP002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No