Single-dose Escalation Trial of M2ES in Healthy Volunteer

Protgen

Status and phase: Completed; Phase 1

Conditions: Cancer

Treatments: Drug: M2ES; Other: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01223924

PG-2008-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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33 participants in 2 patient groups, including a placebo group

M2ES 7.5-90mg

Experimental group

Description:

M2ES dose escalating

Treatment:

Drug: M2ES

Placebo

Placebo Comparator group

Description:

placebo contract

Treatment:

Other: placebo