Deuteporfin Tolerance and Pharmacokinetics in Healthy Volunteers

NCT01481597 | Completed Phase 1

• 1 other identifier: FDZJ1109DT
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

deuteporfin; safety; tolerability; pharmacokinetics; healthy volunteers

Outcome Measures

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

  up to 19 days following injection

Secondary Outcomes (1)

• 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

Study Arms (5)

deuteporfin 1mg/kg

EXPERIMENTAL

Drug: deuteporfin

deuteporfin 2.5mg/kg

ACTIVE COMPARATOR

Drug: deuteporfin

deuteporfin 5mg/kg

ACTIVE COMPARATOR

Drug: deuteporfin

deuteporfin 7.5mg/kg

ACTIVE COMPARATOR

Drug: deuteporfin

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

deuteporfin DRUG

deuteporfin 1 mg/kg IV as a single dose

deuteporfin 1mg/kg

placebo DRUG

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

placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese healthy male and/or female subjects
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Xiangya Hospital of Central-South University

Changsha, Hunan, 410008, China

Location

Study Officials

• Zeneng Cheng, Ph.D

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

• Jining Tao, Master

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

  STUDY DIRECTOR

• Pingsheng Xu, Master

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2011
• First Posted: November 29, 2011
• Study Start: November 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 16, 2012

Record last verified: 2012-05

Locations

CN (1)