Single-dose Escalation Trial of M2ES in Healthy Volunteer

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: Cancer
• Intervention / Treatment: Other: placebo; Drug: M2ES

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	Pharmacokinetic (PK) behavior of two different doses in healthy volunteers	3 weeks

Collaborators and Investigators

• Sponsor: Protgen Ltd
• Investigators: Principal Investigator: Ji JIANG, MD, Perking Union Medical College Hospital

Study record dates

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: cancer
• Other Study ID Numbers: PG-2008-1