Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A tolerability, safety study of single dose progressively increasing, random, double-blinded placebo-controlled in healthy volunteers

Trial Profile

A tolerability, safety study of single dose progressively increasing, random, double-blinded placebo-controlled in healthy volunteers

Status: Recruiting
Phase of Trial: Phase I

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
  • Most Recent Events

    • 23 Sep 2014 New trial record

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
222 Middle Huaihai Road
+86 21 6093 8228-3332
anne.rong@techpool.com.cn
show details
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
Gaotang Scien-tech Industrial Park Tianhe Guangzhou 510520
show details
-
China
Techpool Bio-Pharma Co., Ltd
89 Gaopu Road
Gaotang Scien-tech Industrial Park Tianhe Guangzhou 510520
show details
Shanghai China

Trial History

Event Date Event Type Comment
23 Sep 2014 New trial record New trial record Updated 23 Sep 2014

References

  1. Chinese Clinical Trial Register. Trial-Reg 2016;.

    Available from: URL: http://www.chictr.org
Back to top