Graft-versus-host DiseasePhase 1NCT05856058
To Assess SHR0302 Oral Solutions and Tablets in Healthy Subjects Clinical Studies of Relative Bioavailability
A Phase 1 study testing SHR0302 in people with Graft-versus-host Disease, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
To assess the relative bioavailability of SHR0302 oral solution and tablet in healthy subjects. To assess the safety and tolerability of a single dose of SHR0302 oral solution and tablet. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Graft-versus-host Disease
- What is being tested?
- SHR0302
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 29 May 2023to 9 Oct 2023
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntarily sign the informed consent form before the start of the activities related to the trial, and be able to understand the procedures and methods of the trial, and be willing to strictly abide by the clinical trial protocol to complete the trial;
- Age 18~45 years old (including both end values, subject to the signing of informed consent), healthy male;
- Weight ≥ 50 kg, and body mass index (BMI): 19~26 kg/m2 (including both end values);
- Sign the informed consent form and agree to use non-pharmacological effective contraception within 60 days after the last dose of the test drug.
Who cannot join
- Those who have a history of tobacco addiction within 3 months before signing the informed consent form (an average of 5 cigarettes smoked > per day), or those who cannot stop using any tobacco products during the study;
- Those who consumed an average of more than 25 g of alcohol per day (e.g., 750 mL of beer, 250 mL of wine, or 50 mL of liquor) per day in the 3 months prior to signing the informed consent form, or who could not stop using any alcohol-containing products during the study, or who had a positive alcohol breath test at screening;
- Eating any drink or food containing grapefruit within 7 days before randomization; or eat any beverage or food containing methylxanthines, such as coffee, tea, cola, chocolate, etc., within 2 days before randomization;
- Allergic constitution, or suspected allergy to any ingredient in SHR0302 drug;
- Drug abusers, or positive urine drug abuse screening at screening, including: morphine, meth (methamphetamine), ketamine, cocaine, ecstasy (MDMA - Methylenedioxymethamphetamine), marijuana (tetrahydrocannabinol acid);
- Have any history of clinically serious diseases or diseases or conditions that the investigator believes may affect the test results, including but not limited to circulatory, endocrine, nervous system, digestive system, urinary system or blood, immune, psychiatric and metabolic diseases;
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- Those who have a history of tuberculosis within 6 months before signing the informed consent form; or those with a positive γ-interferon release test (IGRA) within 4 weeks prior to randomization;
- 12-lead ECG QTcF > 450 ms or other abnormalities judged clinically significant by the investigator in the first 4 weeks of randomization;
- Vital signs, physical examination, laboratory tests, abdominal ultrasound or chest imaging in the first 4 weeks of randomization suggest that there are abnormalities that are judged to be clinically significant by the investigator;
- Within 4 weeks before randomization, hepatitis B surface antigen (HBsAg) positive, or anti-hepatitis C virus (HCV) antibody positive, or human immunodeficiency virus (HIV) antibody positive, or syphilis antibody positive;
- Infections (viral, bacterial, fungal, parasitic infections) that require systemic antimicrobial therapy within 4 weeks of randomization;
- Use of any prescription drug, over-the-counter drug, Chinese herbal medicine or dietary supplement within 2 weeks prior to randomization;
- Systemic therapy with inhibitors or inducers of cytochrome P450 3A4 enzyme (CYP3A4) within 4 weeks before randomization (see Annex 2 for details);
- Those who participated in any drug clinical trial and took the experimental drug within 3 months before randomization (calculated from the start time of the last visit of the last trial) (if the 5 half-lives of the experimental drug exceed 3 months, the time of the 5 half-lives shall prevail);
- Have received BCG vaccine within 12 months prior to randomization; or vaccination or exposure to other live vaccines or live attenuated vaccines within the first 3 months of randomization; or those who plan to be vaccinated during the trial;
- Those who have undergone any surgery within the previous 3 months of randomization, or who have not recovered after surgery, or who may have surgery or hospitalization plans during the estimated trial period;
- Those who donate blood (or lose blood) within 3 months of randomization and donate blood (or blood loss) in an amount ≥ 400 mL, or receive blood transfusion;
- The investigator judges that the subject has a situation that affects the absorption, distribution, metabolism and excretion of drugs, or has other factors that are not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Assess SHR0302 Oral Solutions and Tablets in Healthy Subjects Clinical Studies of Relative Bioavailability (Single-center, Random, Open, Crossed)
To assess the relative bioavailability of SHR0302 oral solution and tablet in healthy subjects.
To assess the safety and tolerability of a single dose of SHR0302 oral solution and tablet.
- Conditions
- Graft-versus-host Disease
- Being tested
- SHR0302
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR0302Drug
SHR0302 oral solution 1 time, SHR0302 tablets 1 time
| Study group | Role | What they receive |
|---|---|---|
| Treatment group ARM 1 | Experimental | SHR0302 tablets, then SHR0302 oral solution Receives: Drug: SHR0302 |
| Treatment group ARM 2 | Experimental | SHR0302 oral solution, then SHR0302 tablets Receives: Drug: SHR0302 |
What is being measured
The primary outcome is the main question the study is designed to answer.
SHR0302 and its main Pk parameter, AUC0-t
Measured: day 1 to 8
SHR0302 and its main Pk parameter, AUC0-inf
Measured: day 1 to 8
SHR0302 and its main Pk parameter, Cmax
Measured: day 1 to 8
Relative bioavailability (F%) value between SHR0302 oral solution and SHR0302 tablet: F% = AUC0-t (oral solution) / AUC0-t (tablet) ×100%
Measured: day 1 to 8
Secondary outcomes (5)
SHR0302 and its main Pk parameter, Tmax (SHR0302 only)
Measured: day 1 to 8
SHR0302 and its main Pk parameter, t1/2 (SHR0302 only)
Measured: day 1 to 8
SHR0302 and its main Pk parameter, CL/F (SHR0302 only)
Measured: day 1 to 8
SHR0302 and its main Pk parameter, Vz/F (SHR0302 only)
Measured: day 1 to 8
Adverse events
Measured: day 1 to 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start29 May 2023
- Primary completion3 Jul 2023
- Study completion9 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft-versus-host DiseaseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT05856058
- Sponsor's protocol ID
- SHR0302-112
- Status last verified
- Dec 2023
- First submitted
- 4 May 2023
- Last updated
- 8 Dec 2023
- 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 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess SHR0302 Oral Solutions and Tablets in Healthy Subjects Clinical Studies of Relative Bioavailability (Single-center, Random, Open, Crossed)
- ClinicalTrials.gov ID
- NCT05856058
- Acronym / sponsor ID
- SHR0302-112
- Conditions
- Graft-versus-host Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 May 2023 (actual)
- Primary completion
- 3 Jul 2023 (actual)
- Study completion
- 9 Oct 2023 (actual)
- First posted
- 12 May 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.
To assess the relative bioavailability of SHR0302 oral solution and tablet in healthy subjects.
To assess the safety and tolerability of a single dose of SHR0302 oral solution and tablet.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group ARM 1 | Experimental | Drug: SHR0302SHR0302 tablets, then SHR0302 oral solution |
| Treatment group ARM 2 | Experimental | Drug: SHR0302SHR0302 oral solution, then SHR0302 tablets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Voluntarily sign the informed consent form before the start of the activities related to the trial, and be able to understand the procedures and methods of the trial, and be willing to strictly abide by the clinical trial protocol to complete the trial;
- Age 18~45 years old (including both end values, subject to the signing of informed consent), healthy male;
- Weight ≥ 50 kg, and body mass index (BMI): 19~26 kg/m2 (including both end values);
- Sign the informed consent form and agree to use non-pharmacological effective contraception within 60 days after the last dose of the test drug.
Key exclusion criteria (18 listed)
- Those who have a history of tobacco addiction within 3 months before signing the informed consent form (an average of 5 cigarettes smoked > per day), or those who cannot stop using any tobacco products during the study;
- Those who consumed an average of more than 25 g of alcohol per day (e.g., 750 mL of beer, 250 mL of wine, or 50 mL of liquor) per day in the 3 months prior to signing the informed consent form, or who could not stop using any alcohol-containing products during the study, or who had a positive alcohol breath test at screening;
- Eating any drink or food containing grapefruit within 7 days before randomization; or eat any beverage or food containing methylxanthines, such as coffee, tea, cola, chocolate, etc., within 2 days before randomization;
- Allergic constitution, or suspected allergy to any ingredient in SHR0302 drug;
- Drug abusers, or positive urine drug abuse screening at screening, including: morphine, meth (methamphetamine), ketamine, cocaine, ecstasy (MDMA - Methylenedioxymethamphetamine), marijuana (tetrahydrocannabinol acid);
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 |
|---|---|---|
| SHR0302SHR0302 oral solution 1 time, SHR0302 tablets 1 time | Drug | Treatment group ARM 1, Treatment group ARM 2 |
Primary outcome
SHR0302 and its main Pk parameter, AUC0-t
Time frame: day 1 to 8
SHR0302 and its main Pk parameter, AUC0-inf
Time frame: day 1 to 8
SHR0302 and its main Pk parameter, Cmax
Time frame: day 1 to 8
Relative bioavailability (F%) value between SHR0302 oral solution and SHR0302 tablet: F% = AUC0-t (oral solution) / AUC0-t (tablet) ×100%
Time frame: day 1 to 8
5 secondary outcomes
SHR0302 and its main Pk parameter, Tmax (SHR0302 only)
Time frame: day 1 to 8
SHR0302 and its main Pk parameter, t1/2 (SHR0302 only)
Time frame: day 1 to 8
SHR0302 and its main Pk parameter, CL/F (SHR0302 only)
Time frame: day 1 to 8
SHR0302 and its main Pk parameter, Vz/F (SHR0302 only)
Time frame: day 1 to 8
Adverse events
Time frame: day 1 to 12
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 8 Dec 2023.
- 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 SHR0302 in people with Graft-versus-host Disease, 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 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 8 Dec 2023. 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?
SHR0302 and its main Pk parameter, AUC0-t (time frame: day 1 to 8). The study lists 4 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 8 Dec 2023.