A Study of SHR0410 in Hemodialysis Patients With Pruritus

Pruritus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04317209
• Other study ID #: SHR0410-103
• Status: Recruiting
• Phase: Phase 1
• Start date: May 17, 2020
• Est. completion date: December 2020

Study information

• Verified date: May 2020
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Jianjun Zou
• Phone: 02168868570
• Email: zoujianjun[@]hrglobe.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the safety, tolerability and pharmacokinetics of SHR0410 in hemodialysis patients with moderate to severe pruritus

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pruritus

Intervention

Drug:
• SHR0410
administered intravenously
• Placebo
administered intravenously

Locations

Country	Name	City	State
China	The first affiliated hospital of sun yat-sen university	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence and severity of any adverse events that occurred between the first administration and the 48-hour period following the last administration	To evaluate the safety and tolerability of repeated doses of SHR0410	up to 7 days
Secondary	Area under drug-time curve	To evaluate pharmacokinetic (PK) of repeated doses of SHR0410	up to 7 days
Secondary	peak time	To evaluate pharmacokinetic (PK) of repeated doses of SHR0410	up to 7 days
Secondary	peak concentration	To evaluate pharmacokinetic (PK) of repeated doses of SHR0410	up to 7 days
Secondary	half-life	To evaluate pharmacokinetic (PK) of repeated doses of SHR0410	up to 7 days
Secondary	apparent clearance rate	To evaluate pharmacokinetic (PK) of repeated doses of SHR0410	up to 7 days
Secondary	apparent distribution volume	To evaluate pharmacokinetic (PK) of repeated doses of SHR0410	up to 7 days
Secondary	The ratio of AUC0-t after the first and last administration.	To evaluate pharmacokinetic (PK) of repeated doses of SHR0410	up to 7 days