A Trial of SHR0410 Injection in Hemodialysis Participants.

Pruritus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03857568
• Other study ID #: SHR0410-102-AU
• Status: Completed
• Phase: Phase 1
• Start date: April 15, 2019
• Est. completion date: November 8, 2019

Study information

• Verified date: July 2020
• Source: Atridia Pty Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: November 8, 2019
• Est. primary completion date: November 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pruritus

Intervention

Drug:
• SHR0410
drug will be dosed repeatedly
• Placebo
Placebo will be dosed repeatedly

Locations

Country	Name	City	State
Australia	Linear Clinical Research	Nedlands	Western Australia(WA)

Sponsors (1)

Lead Sponsor	Collaborator
Atridia Pty Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse events in terms of changes in Hematology	Hemoglobin Hematocrit Erythrocytes count Mean cell volume, Mean cell hemoglobin concentration, Leukocytes count, Neutrophils count, Lymphocytes count, Monocytes count, Eosinophils count, Basophils count, Platelets count	14 days
Primary	Incidence of Adverse events in terms of changes in Urinalysis	Urobilinogen Dipstick urinalysis, including: pH, Specific gravity, Protein, Blood, Leukocytes, Glucose, Ketones, Bilirubin, Nitrites	14 days
Primary	Incidence of Adverse events in terms of changes in Biochemistry	Including Serum creatinine, Urea, Alanine aminotransferase, Aspartate aminotransferase, Gamma glutamyl transferase, Total bilirubin, Total protein, Albumin, Alkaline phosphatase, Serum uric acid, Glucose, Triglycerides, Total cholesterol, High-density lipoprotein cholesterol, Low-density lipoprotein cholesterol	14 days
Primary	Incidence of Adverse events in terms of changes in 12-lead ECGs	The 12-lead ECGs must be recorded after the subjects have rested in the supine position for 5 minutes to ensure a stable baseline	14 days
Secondary	Area under the plasma concentration versus time curve (AUC)	Plasma SHR0410 Area Under the Concentration-time Curve (AUC)	Up to 24 hours post dose
Secondary	Time to the peak plasma concentration (Tmax)	Time to Maximum Plasma SHR0410 Concentration	Up to 24 hours post dose
Secondary	Peak Plasma Concentration (Cmax)	Peak Plasma SHR0410 Concentration	Up to 24 hours post dose
Secondary	Half-time (T1/2)	Half-time of SHR0410	Up to 24 hours post dose