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Status unknownNCT00425971Updated Sep 4, 2008

Safety Study of Anti-Asthma Agent BMEC-1217B

A Phase 1 interventional study of BMEC-1217B in Asthma, sponsored by Medigreen Biotechnology Corp.. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-09-04.

Sponsored by Medigreen Biotechnology Corp. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2008), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
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Study 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.

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Conditions studied

  • Asthma

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03

In context

Asthma

3,920 studies on the registry are indexed under Asthma; 506 are open to participants now.

This study's planned enrollment of 32 is below the median of 83 across 2,751 interventional studies indexed under Asthma.

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Lead sponsor

This is the only study on the registry with Medigreen Biotechnology Corp. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
32 participants (estimated)

Interventions

  • DrugBMEC-1217B
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Study locations

1 of 1 sites recruiting
  • Tri-Service General Hospital
    Taipei, 114, Taiwan
    • Renee Ding, CRA · Contact · renee@medigreen.com · 886-82596859
    • Horng-Chin Yan, M.D., Ph.D. · Principal investigator
    Recruiting
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00425971
Lead sponsor
Medigreen Biotechnology Corp.
First posted
Jan 24, 2007
Start date
Jul 2008
Last update
Sep 4, 2008

Study contacts

Renee Ding, CRA
Contact
renee@medigreen.com
886-2-82596859 ext. 874
Horng-Chin Yan, M.D., Ph.D.
principal investigator · Tri-Service General Hospital, Taipei, Taiwan
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.

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