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Autoimmune DiseasesPhase 1NCT06202612

A SHR0302 BA Study on Healthy Subjects

A Phase 1 study testing SHR0302 quick release tablets and SHR0302 sustained-release tablets in people with Autoimmune Diseases, 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.

Official record
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Trial summary

The purpose of this study is to evaluate and compare the pharmacokinetics of SHR0302 two different kind tablets in Healthy subjects after administration two kind tablets (quick release tablets and sustained-release tablets). Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Autoimmune Diseases
What is being tested?
SHR0302 quick release tablets and SHR0302 sustained-release tablets
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
16 Jan 2024to 21 Feb 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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male or female healthy subjects aged 18 to 60 (including 18 and 60);
  • Weigh at least 50 kg (for male) and 45 kg (for female), respectively, and have a body mass index (BMI) ≥ 19 and ≤26 kg/m2. BMI = weight (kg)/[height (m)]2;
  • From the signing of the informed consent form until 6 months after the last administration, the subject (including partner) has no family planning and is willing to use the high-efficiency contraceptive measures specified in the plan;
  • Sign the informed consent before the trial, and fully understand the content, process and possible adverse reactions of the trial. Must be able to communicate with the investigator, understand and comply with all study requirements.

Who cannot join

  • Any clinical history of serious diseases or conditions that the researcher believes may affect the trial results, including but not limited to circulatory system, endocrine system, nervous system, digestive system, urinary system or blood, immune, mental and metabolic disease history;
  • Those who have a history of tuberculosis within 6 months before signing the informed consent form; Or those who tested positive for T-spot test within the first 4 weeks of randomization;
  • Individuals who have a history of smoking (average daily smoking>5 cigarettes) within the 3 months prior to signing the informed consent form, or who cannot stop using any tobacco products during the study period;
  • Those who consume more than 25 g of alcohol per day on average within three months before signing the informed consent form (for example, 750 mL of beer, 250 mL of wine, or 50 mL of Baijiu), or cannot stop using any alcoholic products during the study period, or those who are positive in the alcohol breath test during screening;
  • Drug abusers, or those who have tested positive for urinary drug abuse during screening, including: morphine, methamphetamine, ketamine, cocaine, ecstasy (dimethylenedioxoamphetamine), marijuana (tetrahydrocannabidiol acid);
  • During the screening period, if the QTc of the ECG examination is greater than 450 ms or there are other clinically significant abnormalities determined by the researcher;
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  • Vital signs, physical examinations, laboratory tests, abdominal ultrasound or chest imaging examinations during the screening period indicate the presence of abnormalities that have been determined by the researchers to be clinically significant;
  • 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;
  • Within the first 7 days of randomization, any beverage or food containing grapefruit, grapefruit, strong tea, coffee, mangoes, etc. was consumed;
  • Allergic constitution, or suspected allergy to any component of SHR0302 medication;
  • Infections that require systemic antimicrobial therapy that occurred within the first 4 weeks of randomization (viral, bacterial, fungal, parasitic infections);
  • Have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or dietary supplements within the first two weeks of randomization;
  • Systemic treatment with inhibitors or inducers of cytochrome P450 3A4 enzyme (CYP3A4) within the first 4 weeks of randomization (see Annex 2 for details);
  • Individuals who participated in any drug clinical trial and took the investigational drug within the first three months of randomization (calculated from the last visit of the previous trial) (if the five half-lives of the investigational drug exceed three months, the time of the five half-lives shall prevail);
  • Received BCG vaccine within the first 12 months of randomization; Or receive or be exposed to other live vaccines or attenuated live vaccines within the first three months of randomization; Or those who plan to receive the vaccine during the trial period;
  • Individuals who have undergone any surgery within the first three months of randomization, or who have not yet recovered after surgery, or who are expected to have surgery or hospitalization plans during the trial period;
  • Individuals who have donated (or lost) blood within the first three months of randomization and have donated (or lost) ≥ 400 mL of blood, or have received blood transfusions;
  • According to the researcher's judgment, the subjects may have factors that affect drug absorption, distribution, metabolism, and excretion, or other factors that are not suitable for participation in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

Other trials in China

About this study

Official title: A Bioavailability Study of SHR0302 Tablet in Healthy Subjects

The purpose of this study is to evaluate and compare the pharmacokinetics of SHR0302 two different kind tablets in Healthy subjects after administration two kind tablets (quick release tablets and sustained-release tablets).

Being tested
SHR0302 quick release tablets, SHR0302 sustained-release tablets
Medical subject headings
Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR0302 quick release tabletsDrug

    SHR0302 quick release tablets 8 mg

  • SHR0302 sustained-release tabletsDrug

    SHR0302 sustained-release tablets 10 mg

Study groups in NCT06202612
Study groupRoleWhat they receive
SHR0302 quick release tablet and sustained-release tabletExperimentalNot described
Receives: Drug: SHR0302 quick release tablets; Drug: SHR0302 sustained-release tablets
SHR0302 sustained-release tablet and quick release tabletExperimentalNot described
Receives: Drug: SHR0302 quick release tablets; Drug: SHR0302 sustained-release tablets

What is being measured

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

  1. PK parameters of SHR0302: Cmax

    Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times after administration on Day 1 and Day 5

  2. PK parameters of SHR0302: AUC0-t

    Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times after administration on Day1 and Day 5

  3. PK parameters of SHR0302: AUC0-inf

    Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times after administration on Day 1 and Day 5

  4. Relative bioavailability (F%) between SHR0302 sustained-release tablets and SHR0302 rapid release tablets

    F%=AUC (sustained-release tablets) * dose (rapid release tablets)/AUC (rapid release tablets) * dose (sustained-release tablets) × 100%

    Measured: Based on pre-dose, 0.25-72 hours post-dose sampling times after administration on Day 1 and Day 5

Secondary outcomes (5)

  1. PK parameters of SHR0302: Tmax

    Measured: 0 hour to 72 hour after administration with sustained-release tablets or rapid release tablets on Day 1 and Day 5

  2. PK parameters of SHR0302: t1/2

    Measured: 0 hour to 72 hour after administration with sustained-release tablets or rapid release tablets on Day 1 and Day 5

  3. PK parameters of SHR0302: CL/F

    Measured: 0 hour to 72 hour after administration with sustained-release tablets or rapid release tablets on Day 1 and Day 5

  4. PK parameters of SHR0302: Vz/F

    Measured: 0 hour to 72 hour after administration with sustained-release tablets or rapid release tablets on Day 1 and Day 5

  5. Adverse events of SHR0302 with sustained-release tablets or rapid release tablets

    Measured: from ICF signing date to day 12 (±1)

Timeline

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

  1. First posted11 Jan 2024
  2. Study start16 Jan 2024
  3. Primary completion21 Feb 2024
  4. Study completion21 Feb 2024

Resources

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
There will be two independent cohorts of subjects who will each receive two treatments (quick release tablets and sustained-release tablets), and each treatment will be followed by 72 hours of blood sampling for pharmacokinetic assessments, with safety and tolerability.
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06202612
Sponsor's protocol ID
SHR0302-113
Status last verified
Apr 2025
First submitted
1 Jan 2024
Last updated
2 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHR0302 quick release tablets and SHR0302 sustained-release tablets in people with Autoimmune Diseases, 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 2 Apr 2025. 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 SHR0302: Cmax (time frame: Based on pre-dose, 0.25-72 hours post-dose sampling times after administration on Day 1 and Day 5). 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?

On the ClinicalTrials.gov record for NCT06202612.

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 2 Apr 2025.

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