Clinical trial · Interventional
Single-dose Escalation Trial of M2ES in Healthy Volunteer
Randomized ，Placebo-controlled,Single-dose Escalation Trial of M2ES in Healthy Volunteer
NCT01223924CI-TRIAL-00004035completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a randomized double-blinded placebo-controlled，single-dose escalation trial in healthy volunteer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| M2ES | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- M2ES 7.5-90mg
- description
- M2ES dose escalating
- interventionNames
- Drug: M2ES
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- placebo contract
- interventionNames
- Other: placebo
Primary outcomes (1)
- measure
- To determine safety, toxicity and maxinum tolerable Dosage of M2ES injection in Safety and tolerability
- timeFrame
- 3 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.