Deuteporfin Tolerance and Pharmacokinetics in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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deuteporfin 1mg/kg

Group Type EXPERIMENTAL

deuteporfin

Intervention Type DRUG

deuteporfin 1 mg/kg IV as a single dose

deuteporfin 2.5mg/kg

Group Type ACTIVE_COMPARATOR

deuteporfin

Intervention Type DRUG

deuteporfin 2.5 mg/kg IV as a single dose

deuteporfin 5mg/kg

Group Type ACTIVE_COMPARATOR

deuteporfin

Intervention Type DRUG

deuteporfin 5 mg/kg IV as a single dose

deuteporfin 7.5mg/kg

Group Type ACTIVE_COMPARATOR

deuteporfin

Intervention Type DRUG

deuteporfin 7.5 mg/kg IV as a single dose

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Interventions

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deuteporfin

deuteporfin 1 mg/kg IV as a single dose

Intervention Type DRUG

deuteporfin

deuteporfin 2.5 mg/kg IV as a single dose

Intervention Type DRUG

deuteporfin

deuteporfin 5 mg/kg IV as a single dose

Intervention Type DRUG

deuteporfin

deuteporfin 7.5 mg/kg IV as a single dose

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes