CancerPhase 1NCT01223924
Single-dose Escalation Trial of M2ES in Healthy Volunteer
A Phase 1 study testing M2ES in people with Cancer, run by Beijing Protgen Biotechnology Development Co., Ltd..
Trial summary
This is a randomized double-blinded placebo-controlled，single-dose escalation trial in healthy volunteer. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- M2ES
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Sep 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- 19 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.
Who cannot join
- 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
About this study
Official title: Randomized ，Placebo-controlled,Single-dose Escalation Trial of M2ES in Healthy Volunteer
This is a randomized double-blinded placebo-controlled，single-dose escalation trial in healthy volunteer.
Read the 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.
- Conditions
- Cancer
- Being tested
- placebo, M2ES
- Keywords
- cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
Also called placebo conparator
placebo
M2ESDrug
Also called M2ES esculating
M2ES IV 7.5mg-90mg
| Study group | Role | What they receive |
|---|---|---|
| M2ES 7.5-90mg | Experimental | M2ES dose escalating Receives: Drug: M2ES |
| Placebo | Placebo comparator | placebo contract Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 weeks
Secondary outcomes (1)
Pharmacokinetic (PK) behavior
Pharmacokinetic (PK) behavior of two different doses in healthy volunteers
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study startMay 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Protgen Biotechnology Development Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ji JIANG, MD, Principal investigator, Perking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223924
- Sponsor's protocol ID
- PG-2008-1
- Status last verified
- Oct 2010
- First submitted
- 9 Oct 2010
- Last updated
- 19 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized ，Placebo-controlled,Single-dose Escalation Trial of M2ES in Healthy Volunteer
- ClinicalTrials.gov ID
- NCT01223924
- Acronym / sponsor ID
- PG-2008-1
- Conditions
- Cancer
- Keywords
- cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Beijing Protgen Biotechnology Development Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 19 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M2ES 7.5-90mg | Experimental | Drug: M2ESM2ES dose escalating |
| Placebo | Placebo comparator | Other: placeboplacebo contract |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
- 19 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboAlso: placebo conparatorplacebo | Other | Placebo |
| M2ESAlso: M2ES esculatingM2ES IV 7.5mg-90mg | Drug | M2ES 7.5-90mg |
Primary outcome
To determine safety, toxicity and maxinum tolerable Dosage of M2ES injection in Safety and tolerability
Time frame: 3 weeks
To determine safety, toxicity and maxinum tolerable Dosage of M2ES injection in Subjects With Advanced Solid Tumors
1 secondary outcome
Pharmacokinetic (PK) behavior
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ji JIANG, MD principal investigator
Perking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing M2ES in people with Cancer, run by Beijing Protgen Biotechnology Development Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine safety, toxicity and maxinum tolerable Dosage of M2ES injection in Safety and tolerability (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2010.