| Trial ID: | L0193 |
| Source ID: | NCT03976115
|
| Associated Drug: |
Ddo-3055
|
| Title: |
A Study to Evaluate the Safety and Efficacy of DDO-3055 in Healthy Volunteers and Patients With Chronic Kidney Disease
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease
|
| Interventions: |
DRUG: DDO-3055|DRUG: Placebos
|
| Outcome Measures: |
Primary: 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) | Secondary: 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|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
|
| Sponsor/Collaborators: |
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
54
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2019-07-18
|
| Completion Date: |
2021-05-11
|
| Results First Posted: |
|
| Last Update Posted: |
2022-06-14
|
| Locations: |
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China
|
| URL: |
https://clinicaltrials.gov/show/NCT03976115
|
