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| Name | Class |
|---|---|
| Shanghai De Novo Pharmatech Co., Ltd. | INDUSTRY |
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This is a double blind Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of DN1406131, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and tryptophan 2,3-Dioxygenase 2 (TDO-2) and help the human immune system attack solid tumor cells more effectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DN1406131 | Experimental | 25 mg,50 mg,100 mg,200 mg,400 mg,600 mg,800 mg |
|
| Placebo | Placebo Comparator | 25 mg,50 mg,100 mg,200 mg,400 mg,600 mg,800 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DN1406131 | Drug | IDO1 and TDO2 inhibitor |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events - type, incidence, severity | Evaluate the safety and toxicity of DN1406131 in healthy volunteers | 28 day |
| Maximum Tolerated Dose | To define the Maximum Tolerated Dose (MTD) | 14 day |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Cmax | 48 hours |
| Serum for biomarkers of IDO activity (kynurenine and tryptophan) | Evaluation of serum for biomarkers of IDO activity (kynurenine and tryptophan), before and after initiation of therapy. Pharmacodynamics（PD） |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wanwan Ji | Contact | 18852605644 | jiwanwan@sh-qingfeng.net | |
| Shunpeng Hu | Contact | +86 13683002413 | hushunpeng@sh-qingfeng.net |
| Name | Affiliation | Role |
|---|---|---|
| Qinghong Zhou | Jiangxi Qingfeng Pharmaceutical Co. Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PKUCare Luzhong Hospital | Recruiting | Zibo | Shandong | 255000 | China |
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| Drug |
Placebo |
|
| 48 hours |
| Elimination half-life | T1/2 | 48 hours |
| peak time | Tmax | 48 hours |