NCT01481597

Deuteporfin Tolerance and Pharmacokinetics in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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
DRUG	placebo	Placebo for 2.5 mg/kg, 5 mg/kg and 7.5mg/kg of deuteporfin (single dose)

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2011-11-29
• Last updated: 2012-05-16

Locations

1 site across 1 country: China