Single-dose Escalation Trial of M2ES in Healthy Volunteer

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01223924
• Other study ID #: PG-2008-1
• Status: Completed
• Phase: Phase 1
• First received: October 9, 2010
• Last updated: October 18, 2010
• Start date: May 2009
• Est. completion date: September 2009

Study information

• Verified date: October 2010
• Source: Protgen Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• placebo
placebo

Drug:
• M2ES
M2ES IV 7.5mg-90mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Protgen Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Pharmacokinetic (PK) behavior	Pharmacokinetic (PK) behavior of two different doses in healthy volunteers	3 weeks	No