Pruritus
Conditions
Brief summary
The aim of this study is to evaluate the safety, tolerability and pharmacokinetics of SHR0410 in hemodialysis patients with moderate to severe pruritus
Interventions
DRUGSHR0410
administered intravenously
DRUGPlacebo
administered intravenously
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Males or females aged 18-65 (inclusive); 2. Weight (\> 50 kg); 3. Patients with end-stage renal disease receiving hemodialysis (including hemodialysis and hemofiltration) three times a week for at least 3 months. 4. VAS≥4 at screening
Exclusion criteria
1. New York cardiac function classification (NYHA) ≥ level III in the current or previous 6 months; 2. Pruritus caused by other than end-stage renal disease or its complications.. 3. History of malignancy 4. Any physical or mental illness or condition, as determined by the study investigator, that may increase the risk of participating the trial, affect the subject's compliance with the protocol, or affect the subject's completion of the trial 5. Positive urine drug screening; Or a history of drug abuse; 6. Urine test positive for nicotine; 7. Alcohol breath test positive; 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or transglutaminase (GGT) was 1.5 times higher than the upper limit of normal value (ULN), or total bilirubin was 1.5 times higher than the upper limit of normal value (ULN); 9. Screening for hepatitis c antibody (HCVAb), syphilis antibody or human immunodeficiency virus (HIV) antibody positive; Or hepatitis B is active; 10. Abnormal electrocardiogram considered inappropriate to participate in this study by the investigator 11. positive for human chorionic gonadotropin (hCG) blood test 12. A history of allergies to opioids 13. Has used opioids within one week prior to the current visit, or cannot avoid to use opioids other than the study drug during the study period; 14. Change the treatment regimen for pruritus within 14 days, or cannot avoid to change the treatment regimen for pruritus during the study period 15. Received Ultraviolet phototherapy within 14 days before screening visit; Or cannot avoid to receive ultraviolet light therapy during the study. 16. Change the treatment regimen of gabapentin, pregabalin, or duloxetine within 14 days before screening visit; Or the treatment regimen of gabapentin, pregabalin, or duloxetine cannot be avoided to be changed during the study period. 17. Change the treatment regimen of medications within 14 days that may affect the judgment of antipruritic effect; Or the treatment regimen cannot be avoided to be changed during the study 18. Using topical antipruritic drugs, such as creams and patches with moisturizing or antipruritic effects at present. 19. Kidney transplantation is expected during the study period; 20. Subjects who had Participated in this trial (defined by signing the informed consent); 21. Subjects who had Participated in clinical trials of any other drugs within the previous 3 months; Or plan to participate in other drug trials during the trial period; 22. Subjects who had Participated in the clinical trial of any medical device within the previous 3 months; Or participate in other medical device tests during the trial period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence and severity of any adverse events that occurred between the first administration and the 48-hour period following the last administration | up to 7 days | To evaluate the safety and tolerability of repeated doses of SHR0410 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| peak time | up to 7 days | To evaluate pharmacokinetic (PK) of repeated doses of SHR0410 |
| peak concentration | up to 7 days | To evaluate pharmacokinetic (PK) of repeated doses of SHR0410 |
| half-life | up to 7 days | To evaluate pharmacokinetic (PK) of repeated doses of SHR0410 |
| Area under drug-time curve | up to 7 days | To evaluate pharmacokinetic (PK) of repeated doses of SHR0410 |
| apparent distribution volume | up to 7 days | To evaluate pharmacokinetic (PK) of repeated doses of SHR0410 |
| The ratio of AUC0-t after the first and last administration. | up to 7 days | To evaluate pharmacokinetic (PK) of repeated doses of SHR0410 |
| apparent clearance rate | up to 7 days | To evaluate pharmacokinetic (PK) of repeated doses of SHR0410 |
Countries
China
Contacts
Primary ContactJianjun Zou
Backup ContactLi Yue
Outcome results
None listed