MedTrace Logo

Deuteporfin Tolerance and Pharmacokinetics in Healthy Volunteers

NCT01481597 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2012-05-16

No results posted yet for this study

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

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)

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Zeneng Cheng, Ph.D · Xiangya Hospital of Central South University

  • Jining Tao, Master · Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

  • Pingsheng Xu, Master · Xiangya Hospital of Central South University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-04-30
Completion
2012-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01481597 on ClinicalTrials.gov