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Completed

NCT Number: NCT01223924

Single-dose Escalation Trial of M2ES in Healthy Volunteer

This is a randomized double-blinded placebo-controlled，single-dose escalation trial in healthy volunteer.

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Key information

Conditions

Cancer Neoplasms

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

Randomized double-blinded placebo-controlled，single-dose escalation trial in health volunteer,to determine the safety and the max tolerate dose in health volunteer.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Other

placebo

Other names: placebo conparator

M2ES

Drug

M2ES IV 7.5mg-90mg

Other names: M2ES esculating

Primary outcomes

  1. To determine safety, toxicity and maxinum tolerable Dosage of M2ES injection in Safety and tolerability

    Time frame: 3 weeks

    To determine safety, toxicity and maxinum tolerable Dosage of M2ES injection in Subjects With Advanced Solid Tumors

Secondary outcomes

  1. Pharmacokinetic (PK) behavior

    Time frame: 3 weeks

    Pharmacokinetic (PK) behavior of two different doses in healthy volunteers

Sponsors and collaborators

Lead sponsor

Protgen Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Oct 19, 2010
Registry last updated
Oct 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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