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Deuteporfin Tolerance and Pharmacokinetics in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01481597
First received: October 10, 2011
Last updated: May 14, 2012
Last verified: May 2012
History of Changes
  Purpose

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 intravenous deuteporfin in healthy Chinese volunteers following single-dose administration.


Condition Intervention Phase
Healthy
 Drug: deuteporfin
Drug: placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tolerance and Pharmacokinetics of Single-dose Intravenous Deuteporfin in Healthy Volunteers

Further study details as provided by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co.,Ltd.:

Primary Outcome Measures:
  • number of participants with adverse events [ Time Frame: up to 19 days following injection ] [ Designated as safety issue: Yes ]
    number of participants with adverse events as a measure of safety and tolerability of single dose of deuteporfin administered to healthy subjects


Secondary Outcome Measures:
  • Pharmacokinetic profile [ Time Frame: predose, 20, 40 and 60 min during-dose, and 5, 10, 20, 40 min and 1, 1.5, 2, 3, 4, 6, 8 ,12, 24h post-dose ] [ Designated as safety issue: No ]
    Pharmacokinetic profile: Cmax (Peak Concentration), AUC (area under the plasma-concentration-time curve ), T1/2 (half life)


Enrollment: 32
Study Start Date: November 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: deuteporfin 1mg/kg Drug: deuteporfin
deuteporfin 1 mg/kg IV as a single dose
Active Comparator: deuteporfin 2.5mg/kg Drug: deuteporfin
deuteporfin 2.5 mg/kg IV as a single dose
Active Comparator: deuteporfin 5mg/kg Drug: deuteporfin
deuteporfin 5 mg/kg IV as a single dose
Active Comparator: deuteporfin 7.5mg/kg Drug: deuteporfin
deuteporfin 7.5 mg/kg IV as a single dose
Placebo Comparator: placebo Drug: placebo
Placebo for 2.5 mg/kg, 5 mg/kg and 7.5mg/kg of deuteporfin (single dose)

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481597

Locations
China, Hunan
Xiangya Hospital of Central-South University
Changsha, Hunan, China, 410008
Sponsors and Collaborators
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co.,Ltd.
Investigators
Principal Investigator: Zeneng Cheng, Ph.D Xiangya Hospital of Central South University
Study Director: Jining Tao, Master Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co.,Ltd.
Principal Investigator: Pingsheng Xu, Master Xiangya Hospital of Central South University
  More Information

No publications provided

Responsible Party: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01481597     History of Changes
Other Study ID Numbers: FDZJ1109DT
Study First Received: October 10, 2011
Last Updated: May 14, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co.,Ltd.:
deuteporfin
safety
tolerability
pharmacokinetics
healthy volunteers

ClinicalTrials.gov processed this record on May 23, 2013