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This is a phase I, randomized, double-blind, placebo-controlled, dose-escalation study in healthy subjects to evaluate safety, tolerability, PKs and PDs of AND017 following oral single and multiple dose administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AND017 single dose escalation | Experimental | Subjects will be administrated with single dose of AND017 capsule from 1 mg to 50 mg during Part A. |
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| AND017 repeated dose escalation | Placebo Comparator | Subjects will be administrated with repeated dose of AND017 from 4 mg to 30 mg for 10 consecutive days during Part B. |
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| Placebo | Placebo Comparator | Placebo administrated once on Day 1 in Part A or daily from Day 1 to Day 10 in Part B |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AND017 single dose | Drug | AND017 administrated as oral single-dose on Day 1 in Part A |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluations | Incidents of AE and abnormal laboratory tests | 17 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Cmax of AND017 | The plasma Cmax of AND017 by single dose administration | 1 day |
| Plasma Tmax of AND017 | The plasma Tmax of AND017 after single dose administration on D1 and multiple doses for 10 consecutive days on D10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yusha Zhu, MD PhD | Kind Pharmaceuticals LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scientia Clinical Research | Randwick | New South Wales | 2031 | Australia |
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| AND017 multiple dose | Drug | AND017 administrated once daily from Day 1 to Day 10 in Part B |
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| Placebo | Drug | Placebo administrated once on Day 1 in Part A or daily from Day 1 to Day 10 in Part B |
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| 1 day and 10 days |
| Plasma t1/2 of AND017 | The plasma T1/2 of AND017 after single dose administration on D1 and multiple doses for 10 consecutive days on D10 | 1 day and 10 days |
| Plasma AUC of AND017 | The plasma AUCs of AND017 after single dose administration on D1 and multiple doses for 10 consecutive days on D10 | 1 day and 10 days |
| Plasma CL/F of AND017 | The plasma CL/F of AND017 after single dose administration | 1 day |
| Plasma Vz/F of AND017 | The plasma Vz/F of AND017 after single dose administration | 1 day |
| Plasma MRT of AND017 | The plasma MRT of AND017 after single dose administration | 1 day |
| Plasma λz of AND017 | The plasma λz of AND017 after single dose administration | 1 day |
| Plasma %AUCex of AND017 | The plasma %AUCex of AND017 after single dose administration | 1 day |
| Plasma Css,min of AND017 | The plasma Css,min of AND017 by multiple administration for 10 consecutive days | 10 days |
| Plasma Css,max of AND017 | The plasma Css,max of AND017 by multiple administration for 10 consecutive days | 10 days |
| Plasma Css,avg of AND017 | The plasma Css,avg of AND017 by multiple administration for 10 consecutive days | 10 days |
| Plasma CLss/F of AND017 | The plasma CLss/F of AND017 by multiple administration for 10 consecutive days | 10 days |
| Plasma Vss/F of AND017 | The plasma Vss/F of AND017 by multiple administration for 10 consecutive days | 10 days |
| Plasma Rac(AUC) of AND017 | The plasma Rac(AUC) of AND017 by multiple administration for 10 consecutive days | 10 days |
| Plasma DF of AND017 | The plasma DF of AND017 by multiple administration for 10 consecutive days | 10 days |
| PD parameters | Change from baseline levels of EPO | 17 days |
| PD parameters | Change from baseline levels of HB | 17 days |
| PD parameters | Change from baseline levels of RET | 17 days |