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This is a randomized, double-blind, dose-escalating, placebo controlled, Phase I study to evaluate the safety, pharmacokinetics and pharmacodynamics of DDO-3055 in healthy volunteers and patients with chronic kidney disease.
48 healthy volunteers will be enrolled in Part A, and 18 patients with chronic kidney disease will be enrolled in Part B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. healthy volunteers | Experimental | 3x single dose of DDO-3055 and placebo |
|
| 2. Patients with chronic kidney disease | Experimental | 3x single dose of DDO-3055 and placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DDO-3055 | Drug | Oral |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events(AEs) and Serious Adverse Events (SAEs) | Incidence of AEs and SAEs, incidence of Treatment-Emergent Adverse Events | from informed consent form signature to the end of the study (up to 14 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) of DDO-3055 | Pre-dose to 72 hours after dose administration | |
| Maximum observed serum concentration (Cmax) of DDO-3055 | Pre-dose to 72 hours after dose administration |
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Inclusion Criteria:
Male or female volunteers aged 18 to 45 years of age inclusive ; Hemoglobin is 120 to 160 g/L; In good health, at the discretion of the investigator, as determined by: medical history, physical examination, vital sign assessment, 12-lead ECG, clinical laboratory evaluations.
- Patients with chronic kidney disease : Male or female patients with chronic kidney disease who are 18 to 45 years of age inclusive; Hemoglobin is ≤100 g/L; 30mL/min/1.73m2 ≤ eGFR ≤ 60mL/min/1.73m2(according to CKD-EPI formula);
Exclusion Criteria:
Healthy volunteers:
- The serum creatinine exceeded the upper limit of normal value in the screening period.
Healthy volunteers and patients with chronic kidney disease:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Placebos |
| Drug |
Oral |
|
| Time to maximum observed serum concentration (tmax) of DDO-3055 | Pre-dose to 72 hours after dose administration |
| Time to elimination half-life (t1/2) of DDO-3055 | Pre-dose to 72 hours after dose administration |
| Apparent total clearance of the drug from plasma after oral administration (CL/F) of DDO-3055 | Pre-dose to 72 hours after dose administration |
| Apparent volume of distribution after non-intravenous administration (V/F) of DDO-3055 | Pre-dose to 72 hours after dose administration |
| Renal clearance of the drug from plasma (CLR) of DDO-3055 | Pre-dose to 72 hours after dose administration |
| Changes in red blood cell count relative to baseline | up to 14 days |
| Changes in reticulocyte count relative to baseline | up to 14 days |
| Changes in hemoglobin relative to baseline | up to 14 days |
| Changes in endogenous erythropoietin relative to baseline | up to 14 days |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |