A Study of SHR0410 in Hemodialysis Patients With Pruritus

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

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

Study Overview

• Status: Unknown
• Conditions: Pruritus
• Intervention / Treatment: Drug: SHR0410; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Guangzhou, China
    • Recruiting
    • The First Affiliated Hospital of Sun Yat-Sen University
    • Contact: Wei Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; administered intravenously
Experimental: SHR0410 low dosage	Drug: SHR0410; administered intravenously; Other Names: KOR agonist
Experimental: SHR0410 medium dosage	Drug: SHR0410; administered intravenously; Other Names: KOR agonist
Experimental: SHR0410 high dosage	Drug: SHR0410; administered intravenously; Other Names: KOR agonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under drug-time curve	To evaluate pharmacokinetic (PK) of repeated doses of SHR0410	up to 7 days
peak time	To evaluate pharmacokinetic (PK) of repeated doses of SHR0410	up to 7 days
peak concentration	To evaluate pharmacokinetic (PK) of repeated doses of SHR0410	up to 7 days
half-life	To evaluate pharmacokinetic (PK) of repeated doses of SHR0410	up to 7 days
apparent clearance rate	To evaluate pharmacokinetic (PK) of repeated doses of SHR0410	up to 7 days
apparent distribution volume	To evaluate pharmacokinetic (PK) of repeated doses of SHR0410	up to 7 days
The ratio of AUC0-t after the first and last administration.	To evaluate pharmacokinetic (PK) of repeated doses of SHR0410	up to 7 days

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: March 16, 2020
• First Submitted That Met QC Criteria: March 20, 2020
• First Posted (Actual): March 23, 2020

Study Record Updates

• Last Update Posted (Actual): May 22, 2020
• Last Update Submitted That Met QC Criteria: May 21, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus
• Other Study ID Numbers: SHR0410-103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No