NCT01223924

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_1 cancer

Timeline
Completed

Started May 2009

Shorter than P25 for phase_1 cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 9, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 19, 2010

Completed
Last Updated

October 19, 2010

Status Verified

October 1, 2010

Enrollment Period

4 months

First QC Date

October 9, 2010

Last Update Submit

October 18, 2010

Conditions

Cancer

Keywords

cancer

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Pharmacokinetic (PK) behavior

    3 weeks

Study Arms (2)

M2ES 7.5-90mg

EXPERIMENTAL

M2ES dose escalating

Drug: M2ES

Placebo

PLACEBO COMPARATOR

placebo contract

Other: placebo

Interventions

placeboOTHER

placebo

Also known as: placebo conparator
Placebo
M2ESDRUG

M2ES IV 7.5mg-90mg

Also known as: M2ES esculating
M2ES 7.5-90mg

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Ji JIANG, MD

    Perking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 9, 2010

First Posted

October 19, 2010

Study Start

May 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

October 19, 2010

Record last verified: 2010-10