PruritusPhase 1NCT04317209
A Study of SHR0410 in Hemodialysis Patients With Pruritus
A Phase 1 study testing SHR0410 in people with Pruritus, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The aim of this study is to evaluate the safety, tolerability and pharmacokinetics of SHR0410 in hemodialysis patients with moderate to severe pruritus Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pruritus
- What is being tested?
- SHR0410
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 17 May 2020to Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged 18-65 (inclusive);
- Weight (> 50 kg);
- Patients with end-stage renal disease receiving hemodialysis (including hemodialysis and hemofiltration) three times a week for at least 3 months.
- VAS≥4 at screening
Who cannot join
- New York cardiac function classification (NYHA) ≥ level III in the current or previous 6 months;
- Pruritus caused by other than end-stage renal disease or its complications..
- History of malignancy
- Any physical or mental illness or condition, as determined by the study investigator, that may increase the risk of participating the trial, affect the subject's compliance with the protocol, or affect the subject's completion of the trial
- Positive urine drug screening; Or a history of drug abuse;
- Urine test positive for nicotine;
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- Alcohol breath test positive;
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or transglutaminase (GGT) was 1.5 times higher than the upper limit of normal value (ULN), or total bilirubin was 1.5 times higher than the upper limit of normal value (ULN);
- Screening for hepatitis c antibody (HCVAb), syphilis antibody or human immunodeficiency virus (HIV) antibody positive; Or hepatitis B is active;
- Abnormal electrocardiogram considered inappropriate to participate in this study by the investigator
- positive for human chorionic gonadotropin (hCG) blood test
- A history of allergies to opioids
- Has used opioids within one week prior to the current visit, or cannot avoid to use opioids other than the study drug during the study period;
- Change the treatment regimen for pruritus within 14 days, or cannot avoid to change the treatment regimen for pruritus during the study period
- Received Ultraviolet phototherapy within 14 days before screening visit; Or cannot avoid to receive ultraviolet light therapy during the study.
- Change the treatment regimen of gabapentin, pregabalin, or duloxetine within 14 days before screening visit; Or the treatment regimen of gabapentin, pregabalin, or duloxetine cannot be avoided to be changed during the study period.
- Change the treatment regimen of medications within 14 days that may affect the judgment of antipruritic effect; Or the treatment regimen cannot be avoided to be changed during the study
- Using topical antipruritic drugs, such as creams and patches with moisturizing or antipruritic effects at present.
- Kidney transplantation is expected during the study period;
- Subjects who had Participated in this trial (defined by signing the informed consent);
- Subjects who had Participated in clinical trials of any other drugs within the previous 3 months; Or plan to participate in other drug trials during the trial period;
- Subjects who had Participated in the clinical trial of any medical device within the previous 3 months; Or participate in other medical device tests during the trial period.
Trial locations and contacts
1 site in 1 country.
Li Yue contact
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of sun yat-sen university
Guangzhou
Wei Chen
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study on Safety, Tolerability and Pharmacokinetics of SHR0410 in Hemodialysis Subjects With Moderate to Severe Pruritus
The aim of this study is to evaluate the safety, tolerability and pharmacokinetics of SHR0410 in hemodialysis patients with moderate to severe pruritus
- Conditions
- Pruritus
- Being tested
- SHR0410, Placebo
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR0410Drug
Also called KOR agonist
administered intravenously
PlaceboDrug
administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| SHR0410 low dosage | Experimental | Not described Receives: Drug: SHR0410 |
| SHR0410 medium dosage | Experimental | Not described Receives: Drug: SHR0410 |
| SHR0410 high dosage | Experimental | Not described Receives: Drug: SHR0410 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of any adverse events that occurred between the first administration and the 48-hour period following the last administration
To evaluate the safety and tolerability of repeated doses of SHR0410
Measured: up to 7 days
Secondary outcomes (7)
Area under drug-time curve
To evaluate pharmacokinetic (PK) of repeated doses of SHR0410
Measured: up to 7 days
peak time
To evaluate pharmacokinetic (PK) of repeated doses of SHR0410
Measured: up to 7 days
peak concentration
To evaluate pharmacokinetic (PK) of repeated doses of SHR0410
Measured: up to 7 days
half-life
To evaluate pharmacokinetic (PK) of repeated doses of SHR0410
Measured: up to 7 days
apparent clearance rate
To evaluate pharmacokinetic (PK) of repeated doses of SHR0410
Measured: up to 7 days
apparent distribution volume
To evaluate pharmacokinetic (PK) of repeated doses of SHR0410
Measured: up to 7 days
The ratio of AUC0-t after the first and last administration.
To evaluate pharmacokinetic (PK) of repeated doses of SHR0410
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start17 May 2020
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317209
- Sponsor's protocol ID
- SHR0410-103
- Status last verified
- May 2020
- First submitted
- 16 Mar 2020
- Last updated
- 22 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study on Safety, Tolerability and Pharmacokinetics of SHR0410 in Hemodialysis Subjects With Moderate to Severe Pruritus
- ClinicalTrials.gov ID
- NCT04317209
- Acronym / sponsor ID
- SHR0410-103
- Conditions
- Pruritus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 May 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 23 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the safety, tolerability and pharmacokinetics of SHR0410 in hemodialysis patients with moderate to severe pruritus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SHR0410 low dosage | Experimental | Drug: SHR0410 |
| SHR0410 medium dosage | Experimental | Drug: SHR0410 |
| SHR0410 high dosage | Experimental | Drug: SHR0410 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females aged 18-65 (inclusive);
- Weight (> 50 kg);
- Patients with end-stage renal disease receiving hemodialysis (including hemodialysis and hemofiltration) three times a week for at least 3 months.
- VAS≥4 at screening
Key exclusion criteria (22 listed)
- New York cardiac function classification (NYHA) ≥ level III in the current or previous 6 months;
- Pruritus caused by other than end-stage renal disease or its complications..
- History of malignancy
- Any physical or mental illness or condition, as determined by the study investigator, that may increase the risk of participating the trial, affect the subject's compliance with the protocol, or affect the subject's completion of the trial
- Positive urine drug screening; Or a history of drug abuse;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR0410Also: KOR agonistadministered intravenously | Drug | SHR0410 high dosage, SHR0410 low dosage, SHR0410 medium dosage |
| Placeboadministered intravenously | Drug | Placebo |
Primary outcome
The incidence and severity of any adverse events that occurred between the first administration and the 48-hour period following the last administration
Time frame: up to 7 days
To evaluate the safety and tolerability of repeated doses of SHR0410
7 secondary outcomes
Area under drug-time curve
Time frame: up to 7 days
peak time
Time frame: up to 7 days
peak concentration
Time frame: up to 7 days
half-life
Time frame: up to 7 days
apparent clearance rate
Time frame: up to 7 days
apparent distribution volume
Time frame: up to 7 days
The ratio of AUC0-t after the first and last administration.
Time frame: up to 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Yue contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR0410 in people with Pruritus, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianjun Zou (02168868570 ext. 02168868570, zoujianjun@hrglobe.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of any adverse events that occurred between the first administration and the 48-hour period following the last administration (time frame: up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2020.