Deuteporfin Tolerance and Pharmacokinetics in Healthy Volunteers

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: deuteporfin; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01481597

FDZJ1109DT

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

32 participants in 5 patient groups, including a placebo group

deuteporfin 1mg/kg

Experimental group

Treatment:

Drug: deuteporfin

Drug: deuteporfin

Drug: deuteporfin

Drug: deuteporfin

deuteporfin 2.5mg/kg

Active Comparator group

Treatment:

Drug: deuteporfin

Drug: deuteporfin

Drug: deuteporfin

Drug: deuteporfin

deuteporfin 5mg/kg

Active Comparator group

Treatment:

Drug: deuteporfin

Drug: deuteporfin

Drug: deuteporfin

Drug: deuteporfin

deuteporfin 7.5mg/kg

Active Comparator group

Treatment:

Drug: deuteporfin

Drug: deuteporfin

Drug: deuteporfin

Drug: deuteporfin

placebo

Placebo Comparator group

Treatment:

Drug: placebo