Single-dose Escalation Trial of M2ES in Healthy Volunteer

October 18, 2010 updated by: Protgen Ltd

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: M2ES 7.5-90mg
M2ES dose escalating
Drug: M2ES
M2ES IV 7.5mg-90mg
Other Names:
  • M2ES esculating
Placebo Comparator: Placebo
placebo contract
Other: placebo
placebo
Other Names:
  • placebo conparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic (PK) behavior
Time Frame: 3 weeks
Pharmacokinetic (PK) behavior of two different doses in healthy volunteers
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Protgen Ltd

Investigators

  • Principal Investigator: Ji JIANG, MD, Perking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

October 9, 2010

First Submitted That Met QC Criteria

October 18, 2010

First Posted (Estimate)

October 19, 2010

Study Record Updates

Last Update Posted (Estimate)

October 19, 2010

Last Update Submitted That Met QC Criteria

October 18, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PG-2008-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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