Trial | NCT01223924  Report issue

Title

Single-dose Escalation Trial of M2ES in Healthy Volunteer
Randomized ，Placebo-controlled,Single-dose Escalation Trial of M2ES in Healthy Volunteer

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    endostatin ...

  • Study Participants

    33
This is a randomized double-blinded placebo-controlled，single-dose escalation trial 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.
Study Started
May 31
2009
Primary Completion
Sep 30
2009
Study Completion
Sep 30
2009
Last Update
Oct 19
2010
Estimate

Other placebo

placebo

  • Other names: placebo conparator

Drug M2ES

M2ES IV 7.5mg-90mg

  • Other names: M2ES esculating

M2ES 7.5-90mg Experimental

M2ES dose escalating

Placebo Placebo Comparator

placebo contract

Criteria 

Inclusion Criteria:

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 Criteria:

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
No Results Posted