Deuteporfin Tolerance and Pharmacokinetics in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: deuteporfin; Drug: placebo

• Registration Number: NCT01481597
• Lead Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-10
• Study Start: 2011-11
• Study First Submitted QC: 2011-11-25
• Study First Posted: 2011-11-29
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-14
• Last Update Posted: 2012-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
deuteporfin 1mg/kg	deuteporfin	-
deuteporfin 5mg/kg	deuteporfin	-
deuteporfin 7.5mg/kg	deuteporfin	-
placebo	placebo	-
deuteporfin 2.5mg/kg	deuteporfin	-

Primary Outcome Measures

Name	Time	Method
number of participants with adverse events	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 Outcome Measures

Name	Time	Method
Pharmacokinetic profile	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)

Trial Locations

Locations (1)

Xiangya Hospital of Central-South University; 🇨🇳 Changsha, Hunan, China