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Completed

NCT Number: NCT01481597

Deuteporfin Tolerance and Pharmacokinetics in Healthy Volunteers

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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Xiangya Hospital of Central-South University

Changsha, Hunan, 410008, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

deuteporfin

Drug

deuteporfin 1 mg/kg IV as a single dose

Placebo

Drug

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

Primary outcomes

  1. number of participants with adverse events

    Time frame: up to 19 days following injection

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

Secondary outcomes

  1. 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

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

Sponsors and collaborators

Lead sponsor

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Tolerance and Pharmacokinetics of Single-dose Intravenous Deuteporfin in Healthy Volunteers

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 29, 2011
Registry last updated
May 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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