A Trial of SHR0410 Injection in Hemodialysis Participants.

NCT ID: NCT03857568

Last Updated: 2020-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2019-11-08

Brief Summary

This is a multi-site study to evaluate the safety and pharmacokinetics of repeated doses of IV SHR0410 in participants who are undergoing hemodialysis.

Detailed Description

This is a multi-site study to evaluate the safety and pharmacokinetics of repeated doses of IV SHR0410 in participants who are undergoing hemodialysis. Twenty-four eligible participants will be enrolled into 3 dose cohorts. SHR0410 will be administered after dialysis session. Safety assessments, PK assessments and efficacy evaluations will be performed.

Conditions

Pruritus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SHR0410 group

SHR0410 will be dosed

Group Type: EXPERIMENTAL

SHR0410

Intervention Type: DRUG

drug will be dosed repeatedly

Placebo

Placebo will be dosed

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Placebo will be dosed repeatedly

Interventions

SHR0410

drug will be dosed repeatedly

Intervention Type: DRUG

Placebo

Placebo will be dosed repeatedly

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Able to understand the study procedures, the risks involved and obtain written informed consent before any study related activity.
• Male or female between the ages of 18 and 75 years, inclusive.
• Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active, throughout the study period and for 28 days following last study drug dosing. Female subjects must be post-menopausal for at least 1 year, permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy) or, if of childbearing potential, must be willing to use a highly effective method of contraception throughout the study period and for 28 days following last study drug dosing.
• Negative drug screen (including alcohol, amphetamines, cocaine, marijuana, opiates, phencyclidine, barbiturates, benzodiazepines, methadone, methamphetamines, tramadol, and tricyclic antidepressants) at screening and on admission to study site.

Exclusion Criteria

• Anticipated to receive a kidney transplant during the study.
• Known history of allergic reaction to opiates such as hives (Note: side effects related to the use of opioids such as constipation or nausea would not exclude the participants from the study).
• Within 12 months prior to screening, known or suspected history of drug abuse or dependence according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atridia Pty Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neil Boudville, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Linear Clinical Research Limited

Locations

Linear Clinical Research

Nedlands, Western Australia(WA), Australia

Countries

Australia

Other Identifiers

SHR0410-102-AU

Identifier Type: -

Identifier Source: org_study_id