A tolerability, safety study of single dose progressively increasing, random, double-blinded placebo-controlled in healthy volunteers
Latest Information Update: 23 Sep 2014
At a glance
- Drugs Ulinastatin (Primary)
- Indications Pancreatitis; Severe acute respiratory syndrome; Vascular disorders
- Focus Adverse reactions
- Sponsors Guangdong Techpool Bio-Pharma
- 23 Sep 2014 New trial record
Most Recent Events
Trial Overview
Purpose
To evaluate the safety and tolerability of single intravenous injecting ulinastatin for injection in healthy volunteers
Other Endpoints
safety, tolerability [1]
Diseases Treated
Indication | Qualifiers | Patient Segments |
---|---|---|
Pancreatitis | treatment | - |
Severe acute respiratory syndrome | treatment | - |
Vascular disorders | treatment | - |
Subjects
- Subject Type volunteers
-
Number
Planned: 51
- Sex male & female
- Age Group 18-45 years; adult
Patient Inclusion Criteria
1.Healthy Chinese male or female subjects, with good healthy condition screening by medical history, body check , vital sign, 12-lead electrocardiograms (ECGs), check radiography, lab results and other checks; 2.Age: ≥18 and ≤45; 3.Weight: ≥45kg, Body mass index≥19 and ≤28kg/M2; 4.Subject can understand the program and the methods, and will follow this clinical scheme and sign the informed consent.
Patient Exclusion Criteria
1.Smoke more than 5 cigarettes a day before screening; 2.Have drug abuse or alcohol abuse history 6 month before screening; 3.Have any severe disease or disease history in cardiovascular, hepatic, renal, gastrointestinal, respiratory endocrine and metabolic, hematologic, neurologic, or psychiatric and other diseases; 4.Have Malignant neoplasm in any organ before the screening, no matter whether the neoplasm has been treated, recurrented or metastasized; 5.Have an abnormal electrocardiogram (ECG); 6.Have any disease history in cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrine, hematologic, neurologic, or other disease history that could affect drug absorbing, metabolism and clearance; 7.Have abnormal lab results; 8.Have disease history or evidence on renal inadequacy, e.g., Cr, usea nitrogen, usea, or other urea constitutional abnormal (e.g., proteinuria); 9.Have server disease or severe infection or injury in past 2 weeks before the study; 10.Have donated blood≥400ML, or have severe lost blood≥400ML in past 3 months; 11.Have an allergic constitution, or have allergic history on drug, or allergy to the test drug or the similar drug; 12.Have attended in other clinical study in past 3 months; 13.Have taken any Prescription Drug, OTC, herbs or food supplements (including vitamins), taken any drugs that would interrupt the data of this study, or taken any drugs or herbs that have toxicity to main organs 14.Subject will be excluded if they are in pregnancies and breastfeeding periods or who has fertility and do not willing to do contraception measurement during the study; 15.HBV and HCV, HIV or syphilis positive; 16.Subject will be excluded if they are considered not to finish this study or they will bring obvious risk.
Trial Details
Identifiers
Identifier | Owner |
---|---|
ChiCTR-TRC14005176 | Chinese Clinical Trial Register |
2014-09 | - |
Organisations
- Sponsors Guangdong Techpool Bio-Pharma
- Affiliations Guangdong Techpool Bio-Pharma
Trial Dates
-
Initiation Dates
Actual : 16 Jul 2014
-
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 | Intravenous |
-
|
Ulinastatin
Intervention: Ulinastatin
Sample Size: 42
Placebo
Sample Size: 9
Trial Centres
Investigators
Investigator | Centre Name | Trial Centre Country |
---|---|---|
Anne rong
3606, Lippo Plaza
show details
222 Middle Huaihai Road +86 21 6093 8228-3332 anne.rong@techpool.com.cn |
Techpool Bio-Pharma Co., Ltd | China |
Centres
Centre Name | Location | Trial Centre Country |
---|---|---|
Shanghai Xuhui District Central Hospital
966 Huaihai Middle Road
show details
|
Shanhai | China |
Techpool Bio-Pharma Co., Ltd
89 Gaopu Road
show details
Gaotang Scien-tech Industrial Park Tianhe Guangzhou 510520 |
-
|
China |
Techpool Bio-Pharma Co., Ltd
89 Gaopu Road
show details
Gaotang Scien-tech Industrial Park Tianhe Guangzhou 510520 |
Shanghai | China |
Trial History
Event Date | Event Type | Comment |
---|---|---|
23 Sep 2014 | New trial record | New trial record Updated 23 Sep 2014 |
References
-
Chinese Clinical Trial Register. Trial-Reg 2021;.
Available from: URL: http://www.chictr.org
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