A Study of SHR0410 in Hemodialysis Patients With Pruritus

NCT04317209 | Unknown Phase 1

• 1 other identifier: SHR0410-103
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Conditions

Pruritus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Area under drug-time curve

  up to 7 days

• peak time

  up to 7 days

• peak concentration

  up to 7 days

• half-life

  up to 7 days

• apparent clearance rate

  up to 7 days

Study Arms (4)

SHR0410 low dosage

EXPERIMENTAL

Drug: SHR0410

SHR0410 medium dosage

EXPERIMENTAL

Drug: SHR0410

SHR0410 high dosage

EXPERIMENTAL

Drug: SHR0410

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SHR0410 DRUG

administered intravenously

Also known as: KOR agonist

SHR0410 high dosage; SHR0410 low dosage; SHR0410 medium dosage

Placebo DRUG

administered intravenously

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged 18-65 (inclusive);
• Weight (\> 50 kg);
• Patients with end-stage renal disease receiving hemodialysis (including hemodialysis and hemofiltration) three times a week for at least 3 months.
• VAS≥4 at screening

You may not qualify if:

• New York cardiac function classification (NYHA) ≥ level III in the current or previous 6 months;
• Pruritus caused by other than end-stage renal disease or its complications..
• History of malignancy
• 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
• Positive urine drug screening; Or a history of drug abuse;
• Urine test positive for nicotine;
• Alcohol breath test positive;
• 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);
• Screening for hepatitis c antibody (HCVAb), syphilis antibody or human immunodeficiency virus (HIV) antibody positive; Or hepatitis B is active;
• Abnormal electrocardiogram considered inappropriate to participate in this study by the investigator
• positive for human chorionic gonadotropin (hCG) blood test
• A history of allergies to opioids
• 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;
• Change the treatment regimen for pruritus within 14 days, or cannot avoid to change the treatment regimen for pruritus during the study period
• Received Ultraviolet phototherapy within 14 days before screening visit; Or cannot avoid to receive ultraviolet light therapy during the study.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The first affiliated hospital of sun yat-sen university

Guangzhou, China

RECRUITING

MeSH Terms

Conditions

Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jianjun Zou

CONTACT

02168868570; zoujianjun@hrglobe.cn

Li Yue

CONTACT

yueli@hrglobe.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 23, 2020
• Study Start: May 17, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 22, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)