NCT03857568

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2019

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

April 15, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2019

Completed
Last Updated

July 10, 2020

Status Verified

July 1, 2020

Enrollment Period

7 months

First QC Date

February 25, 2019

Last Update Submit

July 8, 2020

Conditions

Pruritus

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (4)

  • Area under the plasma concentration versus time curve (AUC)

    Up to 24 hours post dose

  • Time to the peak plasma concentration (Tmax)

    Up to 24 hours post dose

  • Peak Plasma Concentration (Cmax)

    Up to 24 hours post dose

  • Half-time (T1/2)

    Up to 24 hours post dose

Study Arms (2)

SHR0410 group

EXPERIMENTAL

SHR0410 will be dosed

Drug: SHR0410

Placebo

EXPERIMENTAL

Placebo will be dosed

Drug: Placebo

Interventions

SHR0410DRUG

drug will be dosed repeatedly

SHR0410 group
PlaceboDRUG

Placebo will be dosed repeatedly

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linear Clinical Research

Nedlands, Western Australia(WA), 6009, Australia

Location

MeSH Terms

Conditions

Pruritus

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Neil Boudville, Ph.D

    Linear Clinical Research Limited

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2019

First Posted

February 28, 2019

Study Start

April 15, 2019

Primary Completion

November 8, 2019

Study Completion

November 8, 2019

Last Updated

July 10, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)