Clinical trial NCT03857568: A Trial of SHR0410 Injection in Hemodialysis Participants.
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled Study of Intravenous SHR0410 to Evaluate Safety and Pharmacokinetics in Hemodialysis Participants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pruritus
Lead sponsor: Atridia Pty Ltd.
Sponsor class: INDUSTRY
First posted: 2019-02-28
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Incidence of Adverse events in terms of changes in Hematology
timeFrame: 14 days
measure: Incidence of Adverse events in terms of changes in Urinalysis
timeFrame: 14 days
measure: Incidence of Adverse events in terms of changes in Biochemistry
timeFrame: 14 days
measure: Incidence of Adverse events in terms of changes in 12-lead ECGs
timeFrame: 14 days
Secondary outcomes:
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: Up to 24 hours post dose
measure: Time to the peak plasma concentration (Tmax)
timeFrame: Up to 24 hours post dose
measure: Peak Plasma Concentration (Cmax)
timeFrame: Up to 24 hours post dose
measure: Half-time (T1/2)
timeFrame: Up to 24 hours post dose
Other outcomes:
Locations:
city: Nedlands
country: Australia
facility: Linear Clinical Research
state: Western Australia(WA)
Study officials:
affiliation: Linear Clinical Research Limited
name: Neil Boudville, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: