| Trial ID: | L0350 |
| Source ID: | NCT04925661
|
| Associated Drug: |
Hec53856
|
| Title: |
HEC53856 Phase Ib Study in Patients With Non-dialysis Renal Anemia
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Diseases|Renal Anemia
|
| Interventions: |
DRUG: HEC53856|DRUG: Roxadustat|DRUG: Placebo
|
| Outcome Measures: |
Primary: Incidence of Adverse Events, To assess the safety and tolerability of therapy by incidence of treatment-emergent adverse events after multiple doses of HEC53856 capsule, Through study completion, an average of 12 weeks. | Secondary: AUC0-t, Area under the concentration versus time curve (AUC) from time zero to the time of the last quantifiable concentration, Day 1(Dosing) until Day 55 after single and multiple drug dosing.|Cmax, Maximum observed plasma concentration, Day 1(Dosing) until Day 55 after single and multiple drug dosing.|Tmax, Time of the maximum observed plasma concentration, Day 1(Dosing) until Day 55 after single and multiple drug dosing.|T½, Apparent terminal elimination half-life, Day 1(Dosing) until Day 55 after single and multiple drug dosing.|Vz/F, Apparent volume of distribution, Day 1(Dosing) until Day 55 after single and multiple drug dosing.|Changes in mean hemoglobin, Changes in mean hemoglobin (Hb) relative to baseline during weeks 8 and 10., week 10|Hemoglobin response, Percentage of subjects who met the hemoglobin response after dosing, week 10|E-AUC0-t, Area under the EPO concentration versus time curve (AUC) from time zero to the time of the last quantifiable concentration, Day 1(Dosing) until Day 55 after single and multiple drug dosing.|Emax, Maximum observed EPO concentration, Day 1(Dosing) until Day 55 after single and multiple drug dosing.|E-Tmax, Time of the maximum observed EPO concentration, Day 1(Dosing) until Day 55 after single and multiple drug dosing.|Serum lipid, Changes in Serum lipid relative to baseline at weeks 8., Up to Day 55|Indicators of iron, Changes in the Indicators of iron relative to baseline at weeks 8., Up to Day 55|High-sensitivity C-reactive protein, Changes in the High-sensitivity C-reactive protein relative to baseline at weeks 8., Up to Day 55|Reticulocytes, Changes in the mean Reticulocytes relative to baseline after doses., Up to Day 85|VEGF, Changes in the VEGF relative to baseline after doses., Up to Day 55
|
| Sponsor/Collaborators: |
Sponsor: Sunshine Lake Pharma Co., Ltd. | Collaborators: Nicoya Therapeutics (Shanghai) Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2021-09-29
|
| Completion Date: |
2023-05-10
|
| Results First Posted: |
|
| Last Update Posted: |
2021-06-24
|
| Locations: |
The sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, China|Zhejiang Provincal People's Hospital, Hangzhou, China|The People's Hospital of Guangxi Zhuang Autonmous Region, Nanning, China|Huashan Hospital, Shanghai, China|Ruijin Hospital, Shanghai, China|First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China|The First Affiliated Hospital of Xiamen University, Xiamen, China|The First Affiliated Hospital of Xinjiang Medical University, Ürümqi, China
|
| URL: |
https://clinicaltrials.gov/show/NCT04925661
|
