A Trial of SHR0410 Injection in Hemodialysis Participants.

A Phase I, Randomized, Double-blind, Placebo-controlled Study of Intravenous SHR0410 to Evaluate Safety and Pharmacokinetics in Hemodialysis Participants.

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

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.

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).