Logo 1 Logo 2

Clinical Trial Details

Trial ID: L0307
Source ID: NCT04317833
Associated Drug: Sss17
Title: A Study of SSS17 in Healthy Subjects
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Anemia in Chronic Kidney Diseases
Interventions: DRUG: SSS17|DRUG: Placebo
Outcome Measures: Primary: AEs, assessment AEs by frequency, severity, up to Day14 or 29 | Secondary: Maximum plasma concentration (Cmax) of SSS17, Plasma samples will be collected and Cmax will be assessed., [ up to 48 hours post-dose]|Area under the concentration-time curve (AUC) of plasma concentration of SSS17, Plasma samples will be collected and the AUC from zero to infinity will be assessed., [ up to 48 hours post-dose]|Time-to-Cmax (Tmax) of SSS 17, Plasma samples will be collected and the Tmax will be assessed from the concentration-time curve., [ up to 48 hours post-dose]|Elimination terminal half-life (t1/2) of SSS17, Plasma samples will be collected and the t1/2 will be assessed., [up to 48 hours post-dose]|Total amount of SSS17 excreted in urine over 24 hours (Ae0-24), Urine sample will be collected at pre-specified intervals and Ae0-24 will be assessed., only for one cohort (up to 72 hours post-dose)|Fraction of SSS17 excretion during each collection interval (Fe0-24), Urine sample will be collected at pre-specified intervals and Fe0-24 will be assessed., only for one cohort (up to 72 hours post-dose)|Total amount of SSS17 excreted in urine over 72 hours (Ae0-72), Urine sample will be collected at pre-specified intervals and Ae0-72 will be assessed., only for one cohort (up to 72 hours post-dose)|Fraction of SSS17 excretion during each collection interval (Fe0-72), Urine sample will be collected at pre-specified intervals and Fe0-72 will be assessed., only for one cohort (up to 72 hours post-dose)|Renal clearance (CLR) of SSS17, Urine sample will be collected at pre-specified intervals and CLR will be assessed., only for one cohort (up to 72 hours post-dose)|EPO concentrations, Change of EPO concentrations from baseline following SSS17, up to 168 hours post-dose.|VEGF concentrations, Change of VEGF concentrations from baseline following SSS17, up to 168 hours post-dose.|Change of RTC from baseline, Change of RTC from baseline following SSS17, up to 168 hours post-dose.|Change of RBC from baseline, Change of RBC from baseline following SSS17, up to 168 hours post-dose.|Change of Hgb from baseline, Change of Hgb from baseline following SSS17, up to 168 hours post-dose.|Change of hepcidin from baseline, Change of serum hepcidin concentrations from baseline following SSS17, up to 168 hours post-dose.
Sponsor/Collaborators: Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.
Gender: ALL
Age: ADULT
Phases: PHASE1
Enrollment: 65
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2020-05-01
Completion Date: 2021-12-31
Results First Posted:
Last Update Posted: 2020-03-23
Locations: Shanghai Public Health Clinical Center, Shanghai, Shanghai, 201203, China
URL: https://clinicaltrials.gov/show/NCT04317833