Deuteporfin Tolerance and Pharmacokinetics in Healthy Volunteers

Study Overview
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: deuteporfin
* Drug: deuteporfin
* Drug: deuteporfin
* Drug: deuteporfin
* Drug: placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: deuteporfin 1mg/kg<br> | Drug: deuteporfin<br>* deuteporfin 1 mg/kg IV as a single dose<br>|
| Active Comparator: deuteporfin 2.5mg/kg<br> | Drug: deuteporfin<br>* deuteporfin 2.5 mg/kg IV as a single dose<br>|
| Active Comparator: deuteporfin 5mg/kg<br> | Drug: deuteporfin<br>* deuteporfin 5 mg/kg IV as a single dose<br>|
| Active Comparator: deuteporfin 7.5mg/kg<br> | Drug: deuteporfin<br>* deuteporfin 7.5 mg/kg IV as a single dose<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* Placebo for 2.5 mg/kg, 5 mg/kg and 7.5mg/kg of deuteporfin (single dose)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile | Pharmacokinetic profile: Cmax (Peak Concentration), AUC (area under the plasma-concentration-time curve ), T1/2 (half life) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deuteporfin, safety, tolerability, pharmacokinetics, healthy volunteers