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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03857568




Registration number
NCT03857568
Ethics application status
Date submitted
25/02/2019
Date registered
28/02/2019
Date last updated
3/07/2019

Titles & IDs
Public title
A Trial of SHR0410 Injection in Hemodialysis Participants.
Scientific title
A Phase I, Randomized, Double-blind, Placebo-controlled Study of Intravenous SHR0410 to Evaluate Safety and Pharmacokinetics in Hemodialysis Participants.
Secondary ID [1] 0 0
SHR0410-102-AU
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pruritus 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SHR0410
Treatment: Drugs - Placebo

Experimental: SHR0410 group 1 - SHR0410 will be dosed

Experimental: SHR0410 group 2 - SHR0410 will be dosed

Experimental: SHR0410 group 3 - SHR0410 will be dosed

Placebo Comparator: Placebo group 4 - Placebo will be dosed


Treatment: Drugs: SHR0410
drug will be dosed repeatedly

Treatment: Drugs: Placebo
Placebo will be dosed repeatedly

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
14 days
Primary outcome [2] 0 0
Incidence of Adverse events in terms of changes in Urinalysis - Urobilinogen Dipstick urinalysis, including: pH, Specific gravity, Protein, Blood, Leukocytes, Glucose, Ketones, Bilirubin, Nitrites
Timepoint [2] 0 0
14 days
Primary outcome [3] 0 0
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
Timepoint [3] 0 0
14 days
Primary outcome [4] 0 0
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
Timepoint [4] 0 0
14 days
Secondary outcome [1] 0 0
Area under the plasma concentration versus time curve (AUC) - Plasma SHR0410 Area Under the Concentration-time Curve (AUC)
Timepoint [1] 0 0
Up to 24 hours post dose
Secondary outcome [2] 0 0
Time to the peak plasma concentration (Tmax) - Time to Maximum Plasma SHR0410 Concentration
Timepoint [2] 0 0
Up to 24 hours post dose
Secondary outcome [3] 0 0
Peak Plasma Concentration (Cmax) - Peak Plasma SHR0410 Concentration
Timepoint [3] 0 0
Up to 24 hours post dose
Secondary outcome [4] 0 0
Half-time (T1/2) - Half-time of SHR0410
Timepoint [4] 0 0
Up to 24 hours post dose

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA,(WA
Recruitment hospital [1] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Atridia Pty Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03857568
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Neil Boudville, Ph.D
Address 0 0
Linear Clinical Research Limited
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lingling Gu, Ph.D
Address 0 0
Country 0 0
Phone 0 0
18036618448
Fax 0 0
Email 0 0
gulingling@hrglobe.cn
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03857568