Overview

A Trial of SHR0410 Injection in Hemodialysis Participants.

Status:
Completed
Trial end date:
2019-11-08
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Atridia Pty Ltd.
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).