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CompletedNCT01481597Updated May 16, 2012

Deuteporfin Tolerance and Pharmacokinetics in Healthy Volunteers

A Phase 1 interventional study of deuteporfin and deuteporfin in Healthy, sponsored by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-05-16.

Sponsored by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

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

02

Conditions studied

  • Healthy

Keywords

  • deuteporfin
  • safety
  • tolerability
  • pharmacokinetics
  • healthy volunteers
03

In context

Lead sponsor

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. is the lead sponsor of 24 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    deuteporfin 1mg/kg

    Drug: deuteporfin

  • Active comparator
    deuteporfin 2.5mg/kg

    Drug: deuteporfin

  • Active comparator
    deuteporfin 5mg/kg

    Drug: deuteporfin

  • Active comparator
    deuteporfin 7.5mg/kg

    Drug: deuteporfin

  • Placebo comparator
    placebo

    Drug: placebo

Interventions

  • Drugdeuteporfin

    deuteporfin 1 mg/kg IV as a single dose

  • Drugdeuteporfin

    deuteporfin 2.5 mg/kg IV as a single dose

  • Drugdeuteporfin

    deuteporfin 5 mg/kg IV as a single dose

  • Drugdeuteporfin

    deuteporfin 7.5 mg/kg IV as a single dose

  • Drugplacebo

    Placebo for 2.5 mg/kg, 5 mg/kg and 7.5mg/kg of deuteporfin (single dose)

06

What researchers measure

Primary outcomes

  1. number of participants with adverse events

    number of participants with adverse events as a measure of safety and tolerability of single dose of deuteporfin administered to healthy subjects

    Time frame: up to 19 days following injection

Secondary outcomes

  1. Pharmacokinetic profile

    Pharmacokinetic profile: Cmax (Peak Concentration), AUC (area under the plasma-concentration-time curve ), T1/2 (half life)

    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

07

Study locations

1 site
  • Xiangya Hospital of Central-South University
    Changsha, Hunan 410008, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01481597
Lead sponsor
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Nov 29, 2011
Start date
Nov 2011
Primary completion
Apr 2012
Completion
Apr 2012
Last update
May 16, 2012

Study contacts

Zeneng Cheng, Ph.D
principal investigator · Xiangya Hospital of Central South University
Jining Tao, Master
study director · Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Pingsheng Xu, Master
principal investigator · Xiangya Hospital of Central South University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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