A Study of SHR0410 in Hemodialysis Patients With Pruritus

Phase 1

• Conditions: Pruritus
• Interventions: Drug: SHR0410; Drug: Placebo

• Registration Number: NCT04317209
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-16
• Study First Submitted QC: 2020-03-20
• Study First Posted: 2020-03-23
• Status Verified: 2020-05
• Study Start: 2020-05-17
• Last Update Submitted: 2020-05-21
• Last Update Posted: 2020-05-22
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR0410 high dosage	SHR0410	-
Placebo	Placebo	-
SHR0410 low dosage	SHR0410	-
SHR0410 medium dosage	SHR0410	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Area under drug-time curve	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
peak time	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
apparent clearance rate	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

Trial Locations

Locations (1)

The first affiliated hospital of sun yat-sen university; 🇨🇳 Guangzhou, China