Randomized ，Placebo-controlled,Single-dose Escalation Trial of M2ES in Healthy Volunteer
19 Years
45 Years
Both
Cancer
Trial Information
Randomized ，Placebo-controlled,Single-dose Escalation Trial of M2ES in Healthy Volunteer
Randomized double-blinded placebo-controlled，single-dose escalation trial in health
volunteer,to determine the safety and the max tolerate dose in health volunteer.
Inclusion Criteria:
1. 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.
2. 19 to 45 years of age.
3. Body mass index (19-25 kg/m2) ,the body weight ≥55kg for male subject,≥45kg for
female.
4. Negative pregnant test, no menstrual period for female.
5. willing to comply with the protocol.
Exclusion Criteria:
1. Be allergic to endostatin
2. Have taken any drug during the last 2 weeks
3. Have Participated any clinical trail during the last 2 week
4. Cardiovasculre, respiratory, Liver, renal, gastro-intestinal hematologic endocrine
and mental disease
5. HIV-1 infected
6. HBV, HBV infected ,Hepatitis B surface antigen positive
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
To determine safety, toxicity and maxinum tolerable Dosage of M2ES injection in Safety and tolerability
Outcome Description:
To determine safety, toxicity and maxinum tolerable Dosage of M2ES injection in Subjects With Advanced Solid Tumors
Outcome Time Frame:
3 weeks
Safety Issue:
Yes
Principal Investigator
Ji JIANG, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Perking Union Medical College Hospital
Authority:
China: Food and Drug Administration
Study ID:
PG-2008-1
NCT ID:
NCT01223924
Start Date:
May 2009
Completion Date:
September 2009
Related Keywords:
- Cancer
- cancer
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