A Trial of SHR0410 Injection in Hemodialysis Participants.
- Registration Number
- NCT03857568
- Lead Sponsor
- Atridia Pty Ltd.
- Brief Summary
This is a multi-site study to evaluate the safety and pharmacokinetics of repeated doses of IV SHR0410 in participants who are undergoing hemodialysis.
- Detailed Description
This is a multi-site study to evaluate the safety and pharmacokinetics of repeated doses of IV SHR0410 in participants who are undergoing hemodialysis. Twenty-four eligible participants will be enrolled into 3 dose cohorts. SHR0410 will be administered after dialysis session. Safety assessments, PK assessments and efficacy evaluations will be performed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
- Able to understand the study procedures, the risks involved and obtain written informed consent before any study related activity.
- Male or female between the ages of 18 and 75 years, inclusive.
- Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active, throughout the study period and for 28 days following last study drug dosing. Female subjects must be post-menopausal for at least 1 year, permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy) or, if of childbearing potential, must be willing to use a highly effective method of contraception throughout the study period and for 28 days following last study drug dosing.
- Negative drug screen (including alcohol, amphetamines, cocaine, marijuana, opiates, phencyclidine, barbiturates, benzodiazepines, methadone, methamphetamines, tramadol, and tricyclic antidepressants) at screening and on admission to study site.
- Anticipated to receive a kidney transplant during the study.
- Known history of allergic reaction to opiates such as hives (Note: side effects related to the use of opioids such as constipation or nausea would not exclude the participants from the study).
- Within 12 months prior to screening, known or suspected history of drug abuse or dependence according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SHR0410 group SHR0410 SHR0410 will be dosed Placebo Placebo Placebo will be dosed
- Primary Outcome Measures
Name Time Method Incidence of Adverse events in terms of changes in Hematology 14 days Hemoglobin Hematocrit Erythrocytes count Mean cell volume, Mean cell hemoglobin concentration, Leukocytes count, Neutrophils count, Lymphocytes count, Monocytes count, Eosinophils count, Basophils count, Platelets count
Incidence of Adverse events in terms of changes in Urinalysis 14 days Urobilinogen Dipstick urinalysis, including: pH, Specific gravity, Protein, Blood, Leukocytes, Glucose, Ketones, Bilirubin, Nitrites
Incidence of Adverse events in terms of changes in Biochemistry 14 days Including Serum creatinine, Urea, Alanine aminotransferase, Aspartate aminotransferase, Gamma glutamyl transferase, Total bilirubin, Total protein, Albumin, Alkaline phosphatase, Serum uric acid, Glucose, Triglycerides, Total cholesterol, High-density lipoprotein cholesterol, Low-density lipoprotein cholesterol
Incidence of Adverse events in terms of changes in 12-lead ECGs 14 days The 12-lead ECGs must be recorded after the subjects have rested in the supine position for 5 minutes to ensure a stable baseline
- Secondary Outcome Measures
Name Time Method Area under the plasma concentration versus time curve (AUC) Up to 24 hours post dose Plasma SHR0410 Area Under the Concentration-time Curve (AUC)
Time to the peak plasma concentration (Tmax) Up to 24 hours post dose Time to Maximum Plasma SHR0410 Concentration
Peak Plasma Concentration (Cmax) Up to 24 hours post dose Peak Plasma SHR0410 Concentration
Half-time (T1/2) Up to 24 hours post dose Half-time of SHR0410
Trial Locations
- Locations (1)
Linear Clinical Research
🇦🇺Nedlands, Western Australia(WA), Australia