A random, paralleled, double-blinded, placebo controlled clinical study of tolerability of ulinastat
Latest Information Update: 28 Apr 2016
At a glance
- Drugs Ulinastatin (Primary)
- Indications Pancreatitis; Severe acute respiratory syndrome; Vascular disorders
- Focus Adverse reactions
- Sponsors Techpool Bio-Pharma
- 28 Apr 2016 New trial record
Most Recent Events
Trial Overview
Purpose
This exploratory research of tolerability for ulinastin for injection is aiming at providing evidence for follow-up clinical study, by a multi-dose a day administration on Chinese healthy adult volunteers
Primary Endpoints
Safety tolerability
Diseases Treated
Indication | Qualifiers | Patient Segments |
---|---|---|
Pancreatitis | treatment | - |
Severe acute respiratory syndrome | treatment | - |
Vascular disorders | treatment | - |
Subjects
- Subject Type volunteers
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Number
Planned: 24
- Sex male & female
- Age Group 18-50 years; adult
Patient Inclusion Criteria
1. Gender:Chinese healthy adult volunteers,male or female; 2. Aged between 18 to 50 years, no more than about 10 years old in same group; 3. Weight: more than 50 kg, and body mass index of 19-24; 4. No allergic history, especially no food and drug allergy by requesting; 5. No fainting of injection or blood history; 6. No significant evidence or abnormal finding in medical history, clinical checks, lab results, 12-lead electrocardiograms (ECGs), X-ray film of chest radiography during the screening period; 7. No abnormal finding history in heart, kidney, digestive tract, nervous system, metabolism system and so on; 8. No other drugs during past 4 weeks; 9. No drug dependency and NO smoking and alcohol addiction by requesting; 10. No abdominal pain, diarrhea and other Gastrointestinal symptoms during past 3 weeks; 11. Make sure subjects take effective contraception during the study and 3 months after the study; 12. All subjects understand the study and possible adverse reactions, volunteered to attend this study and sign the informed consent.
Patient Exclusion Criteria
1. Have any significant cardiovascular, hepatic, renal, gastrointestinal, respiratory endocrine and metabolic, hematologic, neurologic, or psychiatric and other diseases; 2. Have history of bronchospasm; 3. Have history of drug abusing by requesting; 4. Have an allergic constitution, or have allergic history on drug,food by requesting; 5.Smoke 5 cigarettes or same amount of tobacco by requesting; 6.Drinking 28 units alcohol everyweek (1 units=285ml beer or 25ml spirits or 1 glass of wine) by requesting or drinking before 48 hours or during the study, or drinking in 24 hours and alcohol test is positive; 7. Taken any drug during the past 4 weeks; 8. Donated blood or loss blood (1 unit or 350ml) during the past 3 months; if blood loss more than 200ml, the subject can be recruited in 60 days after the blood donated /loss; 9. Taken known drug damage on main organs during the past 3 months; 10. Attending on anther clinical study or attended it 3 month before this study; 11. Have abnormal lab results during screening period; 12. hepatitis positive, including hepatitis B surface antigen and anti-HCV antibody; 13. HIV or syphilis positive; 14. HCG test positive (blood HCG or urine HCG); 15. Menstrual,pregnancy or breast-feeding; 16. Subject cannot understand the scheme or cannot communicate or cooperate with researches; 17. Considered not fit to attend this study on other factors.
Trial Details
Identifiers
Identifier | Owner |
---|---|
ChiCTR-TRC14005221 | Chinese Clinical Trial Register |
2014PHA006-01 | - |
Organisations
- Sponsors Techpool Bio-Pharma
- Affiliations Techpool Bio-Pharma
Trial Dates
-
Initiation Dates
Actual : 25 Jul 2014
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End Dates
Planned : 31 Dec 2014
Other Details
- Design double-blind; parallel; prospective; randomised
- Phase of Trial Phase I
- Location China
- Focus Adverse reactions
Interventions
Drugs | Route | Formulation |
---|---|---|
UlinastatinPrimary Drug |
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|
Injection |
Test drug group
Measure: Ulinastatin for Injection, Sample Size: 18
control
Measure: Ulinastatin for Injection, Sample Size: 6
Trial Centres
Investigators
Investigator | Centre Name | Trial Centre Country |
---|---|---|
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|
Peking University People's Hospital, Techpool Bio-Pharma CO.,LTD | China |
Fang Yi
NO.133 Avenue, Fuchengnei, Xicheng District, Beijing +86 010-66583834 fygk7000@163.com
show details
|
-
|
|
Rong Lianchen
Suite 3606,
show details
Lippo Plaza, 222 Huaihai Zhong Road +86 13817512744 anne.rong@techpool.com.cn |
Techpool Bio-Pharma CO., LTD |
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|
Centres
Centre Name | Location | Trial Centre Country |
---|---|---|
- | Beijing |
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|
Peking University People's Hospital | Beijing | China |
Techpool Bio-Pharma CO., LTD |
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|
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Techpool Bio-Pharma CO., LTD |
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|
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Techpool Bio-Pharma CO.,LTD | Guangdong | China |
Trial History
Event Date | Event Type | Comment |
---|---|---|
28 Apr 2016 | New trial record | New trial record Updated 28 Apr 2016 |
References
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Chinese Clinical Trial Register. Trial-Reg 2021;.
Available from: URL: http://www.chictr.org
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