HyperuricemiaPhase 1NCT06168929
Bioequivalence Study of 2 Sizes of SHR4640 Tablets Orally in Healthy Subjects
A Phase 1 study testing SHR4640 in people with Hyperuricemia, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the pharmacokinetic, and safety of two sizes of SHR4640 tablets in healthy adults, to explore the bioequivalence between two sizes of SHR4640 tablets. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperuricemia
- What is being tested?
- SHR4640
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 13 Dec 2023to 13 Jan 2024
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able and willing to provide a written informed consent.
- 18 years to 45 years (inclusive).
- Body weight should above 45 kg, and body mass index should be between 19 and 28 kg/m2 (inclusive).
- The physical examination, vital signs, laboratory examination and electrocardiogram are not abnormal or abnormal but with no clinical significance.
Who cannot join
- Pregnant or nursing women.
- No birth control 1 weeks before screening or until one week after SHR4640 administration.
- Average daily alcohol consume more than 14g for female or more than 28g for male within 1 month before screening, or baseline alcohol screening is positive.
- Smokers (average daily smoking of 5 cigarettes or more in the 3 months before screening).
- Subject with a history of substance abuse and drug abuse.
- The investigators determined that other conditions were inappropriate for participation in this clinical trial.
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- sUA level ≥480 μmol/L.
- eGFR < 90 mL/min/1.73 m2.
- Positive result for human immunodeficiency virus (HIV), hepatitis C virus antibody, or syphilis antibody, or hepatitis B surface antigen.
- 12-lead electrocardiogram (ECG) showed abnormal and clinically significant.
- Cardiovascular, neuropsychiatric, respiratory, digestive tract, endocrine and other systemic diseases within 1 year before screening, which were judged to be serious by the investigators.
- History of hypersensitivity to SHR4640 or its analogues.
- History or suspected crystals or stones in the urinary system during the screening period of B-ultrasound.
- History of been diagnosed with acute kidney injury in the past or screening period.
- Had undergone major surgery within 3 months prior to screening, or have not recovered from surgery, or plan major surgery during the study.
- Blood donation within 1 month before screening; Or patients with trauma or major surgical procedures who donated blood or lost blood > 400 mL in the 3 months prior to screening.
- Has unsuitable venous for blood sampling.
- Received the last dose of a study drug (or treatment with a medical device) within 3 months or 5 T1/2 (whichever is longer) of the screening or are currently participating in another study of a study drug (or medical device).
- Have received or been exposed to other live vaccines or live attenuated vaccines within 3 months prior to Day 1, or who plan to receive live vaccines or live attenuated vaccines during the study.
- Consumes grapefruit and/or poppy seed within 48 hours before SHR4640 administration.
- Taken any prescription drugs, over-the-counter drugs, herbal medicines or food supplements within 2 weeks before screening.
Trial locations and contacts
1 site in 1 country.
China1 site
Central Hospital Affilated to Shandong First Medical University
Jinan, Shandong, 250013
About this study
Official title: Bioequivalence Study of 2 Sizes of SHR4640 Tablets in Healthy Subjects (Randomized, Open, Single Dose, Two Sequences, Two Cycles, Self-Crossover Control)
The study is being conducted to evaluate the pharmacokinetic, and safety of two sizes of SHR4640 tablets in healthy adults, to explore the bioequivalence between two sizes of SHR4640 tablets.
- Conditions
- Hyperuricemia
- Being tested
- SHR4640
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR4640Drug
SHR4640, 2.5mg*4 - 10mg*1
SHR4640Drug
SHR4640, 10mg*1 - 2.5mg*4
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Not described Receives: Drug: SHR4640 |
| Treatment group B | Experimental | Not described Receives: Drug: SHR4640 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters of SHR4640: Cmax
Measured: 0 hour to 72 hour after administration
PK parameters of SHR4640: AUC0-t
Measured: 0 hour to 72 hour after administration
PK parameters of SHR4640: AUC0-inf
Measured: 0 hour to 72 hour after administration
Secondary outcomes (5)
PK parameters of SHR4640: Tmax
Measured: 0 hour to 72 hour after administration
PK parameters of SHR4640: t1/2
Measured: 0 hour to 72 hour after administration
PK parameters of SHR4640: CL/F
Measured: 0 hour to 72 hour after administration
PK parameters of SHR4640: Vz/F
Measured: 0 hour to 72 hour after administration
Adverse events
Measured: from ICF signing date to approximate day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start13 Dec 2023
- Primary completion13 Jan 2024
- Study completion13 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies 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
- Crossover
- Model description
- Randomized, Open, Single Dose, Two Sequences, Two Cycles, Self-Crossover Control
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
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
- NCT06168929
- Sponsor's protocol ID
- SHR4640-112
- Status last verified
- Jan 2024
- First submitted
- 5 Dec 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of 2 Sizes of SHR4640 Tablets in Healthy Subjects (Randomized, Open, Single Dose, Two Sequences, Two Cycles, Self-Crossover Control)
- ClinicalTrials.gov ID
- NCT06168929
- Acronym / sponsor ID
- SHR4640-112
- Conditions
- Hyperuricemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 13 Jan 2024 (actual)
- Study completion
- 13 Jan 2024 (actual)
- First posted
- 13 Dec 2023 (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 pharmacokinetic, and safety of two sizes of SHR4640 tablets in healthy adults, to explore the bioequivalence between two sizes of SHR4640 tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, Open, Single Dose, Two Sequences, Two Cycles, Self-Crossover Control
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: SHR4640 |
| Treatment group B | Experimental | Drug: SHR4640 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Able and willing to provide a written informed consent.
- 18 years to 45 years (inclusive).
- Body weight should above 45 kg, and body mass index should be between 19 and 28 kg/m2 (inclusive).
- The physical examination, vital signs, laboratory examination and electrocardiogram are not abnormal or abnormal but with no clinical significance.
Key exclusion criteria (21 listed)
- Pregnant or nursing women.
- No birth control 1 weeks before screening or until one week after SHR4640 administration.
- Average daily alcohol consume more than 14g for female or more than 28g for male within 1 month before screening, or baseline alcohol screening is positive.
- Smokers (average daily smoking of 5 cigarettes or more in the 3 months before screening).
- Subject with a history of substance abuse and 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 |
|---|---|---|
| SHR4640SHR4640, 2.5mg*4 - 10mg*1 | Drug | Treatment group A |
| SHR4640SHR4640, 10mg*1 - 2.5mg*4 | Drug | Treatment group B |
Primary outcome
PK parameters of SHR4640: Cmax
Time frame: 0 hour to 72 hour after administration
PK parameters of SHR4640: AUC0-t
Time frame: 0 hour to 72 hour after administration
PK parameters of SHR4640: AUC0-inf
Time frame: 0 hour to 72 hour after administration
5 secondary outcomes
PK parameters of SHR4640: Tmax
Time frame: 0 hour to 72 hour after administration
PK parameters of SHR4640: t1/2
Time frame: 0 hour to 72 hour after administration
PK parameters of SHR4640: CL/F
Time frame: 0 hour to 72 hour after administration
PK parameters of SHR4640: Vz/F
Time frame: 0 hour to 72 hour after administration
Adverse events
Time frame: from ICF signing date to approximate day 13
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 23 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 SHR4640 in people with Hyperuricemia, 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 21 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 23 Jan 2024. 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?
PK parameters of SHR4640: Cmax (time frame: 0 hour to 72 hour after administration). The study lists 3 primary outcomes in all. 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 23 Jan 2024.