Status:
COMPLETED
Single-dose Escalation Trial of M2ES in Healthy Volunteer
Lead Sponsor:
Protgen Ltd
Conditions:
Cancer
Eligibility:
All Genders
19-45 years
Phase:
PHASE1
Brief Summary
This is a randomized double-blinded placebo-controlled，single-dose escalation trial in healthy volunteer.
Detailed Description
Randomized double-blinded placebo-controlled，single-dose escalation trial in health volunteer,to determine the safety and the max tolerate dose in health volunteer.
Eligibility Criteria
Inclusion
- Physical and mental healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, electrocardiogram (ECG), vital signs, and the results of blood biochemistry, blood coagulation and hematology tests and a urinalysis carried out at screening.
- 19 to 45 years of age.
- Body mass index (19-25 kg/m2) ,the body weight ≥55kg for male subject,≥45kg for female.
- Negative pregnant test, no menstrual period for female.
- willing to comply with the protocol.
Exclusion
- Be allergic to endostatin
- Have taken any drug during the last 2 weeks
- Have Participated any clinical trail during the last 2 week
- Cardiovasculre, respiratory, Liver, renal, gastro-intestinal hematologic endocrine and mental disease
- HIV-1 infected
- HBV, HBV infected ,Hepatitis B surface antigen positive
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01223924
Start Date
May 1 2009
End Date
September 1 2009
Last Update
October 19 2010
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