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A random, paralleled, double-blinded, placebo controlled clinical study of tolerability of ulinastat

Trial Profile

A random, paralleled, double-blinded, placebo controlled clinical study of tolerability of ulinastat

Status: Recruiting
Phase of Trial: Phase I

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
  • Most Recent Events

    • 28 Apr 2016 New trial record

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
  • 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

  • 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
-
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
-
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,
Lippo Plaza,
222 Huaihai Zhong Road
+86 13817512744
anne.rong@techpool.com.cn
show details
Techpool Bio-Pharma CO., LTD
-

Centres

Centre Name Location Trial Centre Country
- Beijing
-
Peking University People's Hospital Beijing China
Techpool Bio-Pharma CO., LTD
-
-
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

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

    Available from: URL: http://www.chictr.org
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