Status:
COMPLETED
A Trial of SHR0410 Injection in Hemodialysis Participants.
Lead Sponsor:
Atridia Pty Ltd.
Conditions:
Pruritus
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 enroll...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2019
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03857568
Start Date
April 15 2019
End Date
November 8 2019
Last Update
July 10 2020
Active Locations (1)
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1
Linear Clinical Research
Nedlands, Western Australia(WA), Australia, 6009