Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| deuteporfin 1mg/kg | Experimental |
| |
| deuteporfin 2.5mg/kg | Active Comparator |
| |
| deuteporfin 5mg/kg | Active Comparator |
| |
| deuteporfin 7.5mg/kg | Active Comparator |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| deuteporfin | Drug | deuteporfin 1 mg/kg IV as a single dose |
| |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zeneng Cheng, Ph.D | Xiangya Hospital of Central South University | Principal Investigator |
| Jining Tao, Master | Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. | Study Director |
| Pingsheng Xu, Master | Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital of Central-South University | Changsha | Hunan | 410008 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
| deuteporfin |
| Drug |
deuteporfin 2.5 mg/kg IV as a single dose |
|
| deuteporfin | Drug | deuteporfin 5 mg/kg IV as a single dose |
|
| deuteporfin | Drug | deuteporfin 7.5 mg/kg IV as a single dose |
|
| placebo | Drug | Placebo for 2.5 mg/kg, 5 mg/kg and 7.5mg/kg of deuteporfin (single dose) |
|