PruritusPhase 1NCT04099927

A Study of SHR4010 in Patients With Hemodialysis

A Phase 1 study testing SHR0410 in people with Pruritus, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The study is being conducted to evaluate the safety and pharmacokinetics of SHR0410 in patients with hemodialysis. 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?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteChina
Study dates: 28 Jul 2019to 15 Jun 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

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 65 years, inclusive;
A total body weight ≥ 50 kg;
End stage of renal disease (ESRD) participants who have been on hemodialysis (including hemodiafiltration) for at least six months and are currently on hemodialysis (including hemodiafiltration) three times a week.
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, and enter the trial only after menstruation is confirmed..

Who cannot join

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);
History of drug abuse in the past;
Nicotine test positive;
Alcohol breath test was positive;
The average daily intake of alcohol in the three months before screening was more than 15 g (15 g alcohol equivalent to 450 ml beer or 150 ml wine or 50 ml low-alcohol liquor).

Show all 18Show fewer

Could not obey the unified dietary arrangements and avoid taking coffee or tea during the study period;
Blood pressure of upper limbs in supine position was : systolic pressure < 110 mmHg, diastolic pressure < 70 mmHg or systolic pressure > 180 mmHg, diastolic pressure > 110 mmHg at screening or pre-dosing after confirmation in a repeat test;
New York Heart Function Classification (NYHA) > III in the screening stage, or abnormal electrocardiogram with clinical significance judged by researchers in the screening stage , including QTcF > 480ms;
Screening alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase > 1.5 × ULN, or total bilirubin> 1.5 × ULN.
Positive at screening for human immunodeficiency virus (HIV) antibody, Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) antibody.
Undergone major surgery within 3 months prior to screening.
Total blood loss ≥ 200 ml within 30 days prior to screening, excluding female bleeding during physiological period.
Blood human chorionic gonadotropin (hCG) test was positive.
Opioids were used within a week before screening, or opioids other than research drugs could not be avoided during the study period.
Previous participation in this trial, as defined by signing informed consent form;
Participation defined as administration of investigational drugs in another clinical trial (including trial with medical devices) 3 months before screening, or currently participating in another clinical trial (including medical device trials);
Any other medical or psychological condition, which in the opinion of the Investigator, might create undue risk to the participant or interfere with the participant's ability to comply with the protocol requirements, or to complete the study.

Trial locations and contacts

1 site in 1 country.

China1 site

Zhongda Hospital Affiliated to Southeast University
Nanjing, Jiangsu, 210009

Other trials in China

About this study

Official title: A Phase I, Open-label Clinical Study on Safety and Pharmacokinetics of SHR0410 Injection for Multiple Administration in Hemodialysis Patients

The study is being conducted to evaluate the safety and pharmacokinetics of SHR0410 in patients with hemodialysis.

Conditions: Pruritus
Being tested: SHR0410
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
SHR0410 monotherapy,given intravenously

Study groups in NCT04099927
Study group	Role	What they receive
SHR0410	Experimental	Experimental: SHR0410 dose escalation. Receives: Drug: SHR0410

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
Measured: Pre-dose to Day13

Secondary outcomes (10)

Assessment of PK parameter-Area under drug-time curve (AUC0-t)
Measured: Pre-dose to Day 6
Assessment of PK parameter-Area under drug-time curve (AUC0-∝)
Measured: Pre-dose to Day 6
Assessment of PK parameter-peak time (Tmax)
Measured: Pre-dose to Day 6
Assessment of PK parameter-peak concentration (Cmax)
Measured: Pre-dose to Day 6
Assessment of PK parameter-half-life (t1/2)
Measured: Pre-dose to Day 6
Assessment of PK parameter-pparent clearance rate (CL)
Measured: Pre-dose to Day 6
Assessment of PK parameter-apparent distribution volume (Vz)
Measured: Pre-dose to Day 6
Pharmacokinetic-The ratio of AUC0-t after the first and last administration.
Measured: Pre-dose to Day 6
The renal clearance rate of SHR0410 in urine after each administration.
Measured: Pre-dose to Day 6
The cumulative excretion rate of SHR0410 in urine after each administration.
Measured: Pre-dose to Day 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jul 201915 Jun 2020

First posted23 Sep 2019
Study start28 Jul 2019
Primary completion20 Apr 2020
Study completion15 Jun 2020

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: Not applicable
Intervention model: Single group
Model description: SHR0410 monotherapy
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04099927
Sponsor's protocol ID: SHR0410-102
Status last verified: May 2020
First submitted: 28 Aug 2019
Last updated: 18 Aug 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pruritus trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Open-label Clinical Study on Safety and Pharmacokinetics of SHR0410 Injection for Multiple Administration in Hemodialysis Patients
ClinicalTrials.gov ID: NCT04099927
Acronym / sponsor ID: SHR0410-102
Conditions: Pruritus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 28 Jul 2019 (actual)
Primary completion: 20 Apr 2020 (actual)
Study completion: 15 Jun 2020 (actual)
First posted: 23 Sep 2019 (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 study is being conducted to evaluate the safety and pharmacokinetics of SHR0410 in patients with hemodialysis.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: SHR0410 monotherapy

Arm	Type	Receives
SHR0410	Experimental	Drug: SHR0410Experimental: SHR0410 dose escalation.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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 65 years, inclusive;
A total body weight ≥ 50 kg;
End stage of renal disease (ESRD) participants who have been on hemodialysis (including hemodiafiltration) for at least six months and are currently on hemodialysis (including hemodiafiltration) three times a week.
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, and enter the trial only after menstruation is confirmed..

Key exclusion criteria (18 listed)

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);
History of drug abuse in the past;
Nicotine test positive;
Alcohol breath test was positive;

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 agonistSHR0410 monotherapy,given intravenously	Drug	SHR0410

Primary outcome

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
Time frame: Pre-dose to Day13

10 secondary outcomes

Assessment of PK parameter-Area under drug-time curve (AUC0-t)
Time frame: Pre-dose to Day 6
Assessment of PK parameter-Area under drug-time curve (AUC0-∝)
Time frame: Pre-dose to Day 6
Assessment of PK parameter-peak time (Tmax)
Time frame: Pre-dose to Day 6
Assessment of PK parameter-peak concentration (Cmax)
Time frame: Pre-dose to Day 6
Assessment of PK parameter-half-life (t1/2)
Time frame: Pre-dose to Day 6
Assessment of PK parameter-pparent clearance rate (CL)
Time frame: Pre-dose to Day 6
Assessment of PK parameter-apparent distribution volume (Vz)
Time frame: Pre-dose to Day 6
Pharmacokinetic-The ratio of AUC0-t after the first and last administration.
Time frame: Pre-dose to Day 6
The renal clearance rate of SHR0410 in urine after each administration.
Time frame: Pre-dose to Day 6
The cumulative excretion rate of SHR0410 in urine after each administration.
Time frame: Pre-dose to Day 6

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.

Related trials for Pruritus

Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Active, not recruiting
Identification of the Mechanism of Non-histaminergic Itch Inducing Epigenetic Changes
Itch
Recruiting
Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
Histamine, Cowhage
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
Recruiting
Topographical Distribution of Itch and Pain Receptors
Pain, Itch

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.

Jianjun Zou study director

Jiangsu HengRui Medicine Co., Ltd.

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 5 inclusion and 18 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: finished, as of the sponsor's last update on 18 Aug 2022. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) (time frame: Pre-dose to Day13). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04099927.

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 18 Aug 2022.