Single-dose Escalation Trial of M2ES in Healthy Volunteer | NCT01223924

Studies
Single-dose Escalation Trial of M2ES in Healthy Volunteer

NCT01223924

Sponsor

Protgen Ltd

Status

Completed

Last Update Posted

Oct 19, 2010Estimated

Enrollment

33Actual

Phase

Phase 1

Conditions

Cancer

Interventions

placebo
M2ES

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Sep 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Oct 9, 2010

First Submission Date that Met QC Criteria

Oct 18, 2010

First Posted Date

Oct 19, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2010

Last Update Posted Date

Oct 19, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
M2ES 7.5-90mg	Experimental	M2ES dose escalating	Drug: M2ES
Placebo	Placebo Comparator	placebo contract	Other: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
placebo	Other	placebo	Placebo	placebo conparator

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Ji JIANG, MD	Perking Union Medical College Hospital	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided