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Safety Study of Anti-Asthma Agent BMEC-1217B

Primary Purpose

Asthma

Status

Unknown status

Phase

Phase 1

Locations

Taiwan

Study Type

Interventional

Intervention

BMEC-1217B

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Nonsmoking healthy adults between 20 and 40 years old.
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].
No recent history of drug or alcohol abuse within one year prior to study enrollment
Signed informed consent form.

Exclusion Criteria:

Has any condition that interferes with the ability of the subject to comply with the requirements of the study.
Has known allergy to the study drug.
Has an acute illness or surgery within 28 days prior to study enrollment
Has participated in other investigational trials within 28 days prior to study enrollment.
Has taken prescription medication and/or over-the-counter medication*4 and/or botanical medications within 28 days prior to study enrollment.
Has alcohol and caffeine consumption within 24 hours prior to the administration of study drug.
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.
Has donation or receive of more than 450 mL of blood within 28 days prior to the study enrollment.
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.
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.
Test positive for HIV, HBV or HCV
Test results indicate liver function failure
Has been diagnosed with Diabetes Mellitus

Sites / Locations

Tri-Service General HospitalRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00425971

First Posted

January 23, 2007

Last Updated

September 3, 2008

Sponsor

Medigreen Biotechnology Corp.

1. Study Identification

Unique Protocol Identification Number

NCT00425971

Brief Title

Safety Study of Anti-Asthma Agent BMEC-1217B

Official Title

A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Dose-Escalating Safety Study of BMEC-1217B, in Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

September 2008

Overall Recruitment Status

Unknown status

Study Start Date

July 2008 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Medigreen Biotechnology Corp.

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

BMEC-1217B

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Nonsmoking healthy adults between 20 and 40 years old. 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]. No recent history of drug or alcohol abuse within one year prior to study enrollment Signed informed consent form. Exclusion Criteria: Has any condition that interferes with the ability of the subject to comply with the requirements of the study. Has known allergy to the study drug. Has an acute illness or surgery within 28 days prior to study enrollment Has participated in other investigational trials within 28 days prior to study enrollment. Has taken prescription medication and/or over-the-counter medication*4 and/or botanical medications within 28 days prior to study enrollment. Has alcohol and caffeine consumption within 24 hours prior to the administration of study drug. 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. Has donation or receive of more than 450 mL of blood within 28 days prior to the study enrollment. 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. 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. Test positive for HIV, HBV or HCV Test results indicate liver function failure Has been diagnosed with Diabetes Mellitus

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Renee Ding, CRA

Phone

886-2-82596859

Ext

874

renee@medigreen.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Horng-Chin Yan, M.D., Ph.D.

Organizational Affiliation

Tri-Service General Hospital, Taipei, Taiwan

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tri-Service General Hospital

City

Taipei

ZIP/Postal Code

114

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Renee Ding, CRA

Phone

886-82596859

Ext

874

renee@medigreen.com

First Name & Middle Initial & Last Name & Degree

Horng-Chin Yan, M.D., Ph.D.

12. IPD Sharing Statement

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Safety Study of Anti-Asthma Agent BMEC-1217B

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