Single-dose Escalation Trial of M2ES in Healthy Volunteer

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: M2ES; Other: placebo

• Registration Number: NCT01223924
• Lead Sponsor: Protgen Ltd

Brief Summary

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

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 Timeline

• Study Start: 2009-05
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2010-10
• Study First Submitted: 2010-10-09
• Study First Submitted QC: 2010-10-18
• Last Update Submitted: 2010-10-18
• Study First Posted: 2010-10-19
• Last Update Posted: 2010-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
M2ES 7.5-90mg	M2ES	M2ES dose escalating
Placebo	placebo	placebo contract

Primary Outcome Measures

Name	Time	Method
To determine safety, toxicity and maxinum tolerable Dosage of M2ES injection in Safety and tolerability	3 weeks	To determine safety, toxicity and maxinum tolerable Dosage of M2ES injection in Subjects With Advanced Solid Tumors

Secondary Outcome Measures

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