Clinical trial NCT04317209: A Study of SHR0410 in Hemodialysis Patients With Pruritus
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study on Safety, Tolerability and Pharmacokinetics of SHR0410 in Hemodialysis Subjects With Moderate to Severe Pruritus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pruritus
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-03-23
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: The incidence and severity of any adverse events that occurred between the first administration and the 48-hour period following the last administration
timeFrame: up to 7 days
Secondary outcomes:
measure: Area under drug-time curve
timeFrame: up to 7 days
measure: peak time
timeFrame: up to 7 days
measure: peak concentration
timeFrame: up to 7 days
measure: half-life
timeFrame: up to 7 days
measure: apparent clearance rate
timeFrame: up to 7 days
measure: apparent distribution volume
timeFrame: up to 7 days
measure: The ratio of AUC0-t after the first and last administration.
timeFrame: up to 7 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The first affiliated hospital of sun yat-sen university
Study officials:
References: