Single-dose Escalation Trial of M2ES in Healthy Volunteer

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01223924

Enrollment

Registered

2010-10-19

Start date

2009-05-31

Completion date

2009-09-30

Last updated

2010-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

cancer

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.

Interventions

OTHERplacebo

placebo

DRUGM2ES

M2ES IV 7.5mg-90mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026