Back to resultsA Trial of SHR0410 Injection in Hemodialysis Participants.
Primary Purpose
Pruritus
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
SHR0410
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pruritus
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).
Sites / Locations
- Linear Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SHR0410 group
Placebo
Arm Description
SHR0410 will be dosed
Placebo will be dosed
Outcomes
Primary Outcome Measures
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
Incidence of Adverse events in terms of changes in Urinalysis
Urobilinogen Dipstick urinalysis, including: pH, Specific gravity, Protein, Blood, Leukocytes, Glucose, Ketones, Bilirubin, Nitrites
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
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
Secondary Outcome Measures
Area under the plasma concentration versus time curve (AUC)
Plasma SHR0410 Area Under the Concentration-time Curve (AUC)
Time to the peak plasma concentration (Tmax)
Time to Maximum Plasma SHR0410 Concentration
Peak Plasma Concentration (Cmax)
Peak Plasma SHR0410 Concentration
Half-time (T1/2)
Half-time of SHR0410
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03857568
Brief Title
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
November 8, 2019 (Actual)
Study Completion Date
November 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atridia Pty Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SHR0410 group
Arm Type
Experimental
Arm Description
SHR0410 will be dosed
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Placebo will be dosed
Intervention Type
Drug
Intervention Name(s)
SHR0410
Intervention Description
drug will be dosed repeatedly
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be dosed repeatedly
Primary Outcome Measure Information:
Title
Incidence of Adverse events in terms of changes in Hematology
Description
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
Time Frame
14 days
Title
Incidence of Adverse events in terms of changes in Urinalysis
Description
Urobilinogen Dipstick urinalysis, including: pH, Specific gravity, Protein, Blood, Leukocytes, Glucose, Ketones, Bilirubin, Nitrites
Time Frame
14 days
Title
Incidence of Adverse events in terms of changes in Biochemistry
Description
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
Time Frame
14 days
Title
Incidence of Adverse events in terms of changes in 12-lead ECGs
Description
The 12-lead ECGs must be recorded after the subjects have rested in the supine position for 5 minutes to ensure a stable baseline
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Area under the plasma concentration versus time curve (AUC)
Description
Plasma SHR0410 Area Under the Concentration-time Curve (AUC)
Time Frame
Up to 24 hours post dose
Title
Time to the peak plasma concentration (Tmax)
Description
Time to Maximum Plasma SHR0410 Concentration
Time Frame
Up to 24 hours post dose
Title
Peak Plasma Concentration (Cmax)
Description
Peak Plasma SHR0410 Concentration
Time Frame
Up to 24 hours post dose
Title
Half-time (T1/2)
Description
Half-time of SHR0410
Time Frame
Up to 24 hours post dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Boudville, Ph.D
Organizational Affiliation
Linear Clinical Research Limited
Official's Role
Principal Investigator
Facility Information:
Facility Name
Linear Clinical Research
City
Nedlands
State/Province
Western Australia(WA)
ZIP/Postal Code
6009
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Trial of SHR0410 Injection in Hemodialysis Participants.
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