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
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multi-dose DDO-3055 tablets in healthy subjects for 7 days.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
| |
| Treatment group B | Experimental |
| |
| Treatment group C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DDO-3055 tablets;Placebo | Drug | Low dose:DDO-3055 tablets for 7 days or Placebo for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects with Adverse Events (AE) | up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) on Day 1 and Day 7 | Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose | |
| Peak plasma concentration (Cmax) on Day 1 and Day 7 | Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chang Su | Contact | +86 156 9951 7837 | suchang@hrglobe.cn | |
| Junye Xiong | Contact | +86 180 3661 8716 | xiongjunye@hrglobe.cn |
Not provided
Not provided
Not provided
Multi-dose, dose escalation study in healthy subjects.
Not provided
Not provided
Not provided
| DDO-3055 tablets;Placebo | Drug | Medium dose:DDO-3055 tablets for 7 days or Placebo for 7 days |
|
| DDO-3055 tablets;Placebo | Drug | High dose:DDO-3055 tablets for 7 days or Placebo for 7 days |
|
| Time to maximum plasma concentration (Tmax) on Day 1 and Day 7 | Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours post-dose |
| Change of endogenous erythropoietin from baseline :Day 1 and Day 7 | 0, 24 hours post dose |
| Change of VEGF from baseline :Day 1 and Day 7 | 0, 24 hours post dose |
| Change of Hb from baseline | Day1, Day7, Day14 |
| Change of Ret from baseline | Day1, Day7, Day14 |
| Change of Hepcidin from baseline | Day1, Day 9 |
| Change of Ferritin from baseline | Day1, Day 9 |
| Change of Serum Iron from baseline | Day1, Day 9 |