Deuteporfin Tolerance and Pharmacokinetics in Healthy Volunteers

Tolerance and Pharmacokinetics of Single-dose Intravenous Deuteporfin 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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: deuteporfin; Drug: deuteporfin; Drug: deuteporfin; Drug: deuteporfin; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: placebo; Placebo for 2.5 mg/kg, 5 mg/kg and 7.5mg/kg of deuteporfin (single dose)
Experimental: deuteporfin 1mg/kg	Drug: deuteporfin; deuteporfin 1 mg/kg IV as a single dose; Drug: deuteporfin; deuteporfin 2.5 mg/kg IV as a single dose; Drug: deuteporfin; deuteporfin 5 mg/kg IV as a single dose; Drug: deuteporfin; deuteporfin 7.5 mg/kg IV as a single dose
Active Comparator: deuteporfin 2.5mg/kg	Drug: deuteporfin; deuteporfin 1 mg/kg IV as a single dose; Drug: deuteporfin; deuteporfin 2.5 mg/kg IV as a single dose; Drug: deuteporfin; deuteporfin 5 mg/kg IV as a single dose; Drug: deuteporfin; deuteporfin 7.5 mg/kg IV as a single dose
Active Comparator: deuteporfin 5mg/kg	Drug: deuteporfin; deuteporfin 1 mg/kg IV as a single dose; Drug: deuteporfin; deuteporfin 2.5 mg/kg IV as a single dose; Drug: deuteporfin; deuteporfin 5 mg/kg IV as a single dose; Drug: deuteporfin; deuteporfin 7.5 mg/kg IV as a single dose
Active Comparator: deuteporfin 7.5mg/kg	Drug: deuteporfin; deuteporfin 1 mg/kg IV as a single dose; Drug: deuteporfin; deuteporfin 2.5 mg/kg IV as a single dose; Drug: deuteporfin; deuteporfin 5 mg/kg IV as a single dose; Drug: deuteporfin; deuteporfin 7.5 mg/kg IV as a single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 19 days following injection

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Pingsheng Xu, Master, Xiangya Hospital of Central South University; Principal Investigator: Zeneng Cheng, Ph.D, Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: October 10, 2011
• First Submitted That Met QC Criteria: November 25, 2011
• First Posted (Estimate): November 29, 2011

Study Record Updates

• Last Update Posted (Estimate): May 16, 2012
• Last Update Submitted That Met QC Criteria: May 14, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: tolerability; safety; pharmacokinetics; healthy volunteers; deuteporfin
• Other Study ID Numbers: FDZJ1109DT