Status:
COMPLETED
Deuteporfin Tolerance and Pharmacokinetics in Healthy Volunteers
Lead Sponsor:
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Deuteporfin, a novel photodynamic drug developed in China, displays good photodynamic antitumor activity. The purpose of the present study is to investigate the safety and pharmacokinetics of intraven...
Eligibility Criteria
Inclusion
- Chinese healthy male and/or female subjects
- 18 to 45 years old with Body mass index (BMI) within the range of 19 to 24 kg/m2
- weigh at least 45 kg for female subjects or 50 kg for male subjects
- In good health as confirmed by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis on the screening and baseline evaluation
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Exclusion
- Significant illness or major surgery within four weeks prior to dosing
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies and photoallergy)
- Use of any drugs which might interfere with drug absorption, distribution, metabolism, excretion or cause photoallergy within 30 days prior to dosing, or any drugs within 14 days prior to dosing
- Participation in any clinical investigation within 30 days prior to dosing
- Smokers, alcoholics, drug abusers
- Immunodeficiency diseases, including a positive HIV test result, Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
- pregnancy or lactation for female subjects
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01481597
Start Date
November 1 2011
End Date
April 1 2012
Last Update
May 16 2012
Active Locations (1)
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1
Xiangya Hospital of Central-South University
Changsha, Hunan, China, 410008