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Single-dose Escalation Trial of M2ES in Healthy Volunteer

NCT ID: NCT01223924

Last Updated: 2010-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-09-30

Brief Summary

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

Detailed Description

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Randomized double-blinded placebo-controlled，single-dose escalation trial in health volunteer,to determine the safety and the max tolerate dose in health volunteer.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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M2ES 7.5-90mg

M2ES dose escalating

Group Type EXPERIMENTAL

M2ES

Intervention Type DRUG

M2ES IV 7.5mg-90mg

Placebo

placebo contract

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

placebo

Interventions

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placebo

placebo

Intervention Type OTHER

M2ES

M2ES IV 7.5mg-90mg

Intervention Type DRUG

Other Intervention Names

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placebo conparator M2ES esculating

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Protgen Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Protgen Ltd

Principal Investigators

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Ji JIANG, MD

Role: PRINCIPAL_INVESTIGATOR

Perking Union Medical College Hospital

Other Identifiers

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PG-2008-1

Identifier Type: -

Identifier Source: org_study_id