LymphomaPhase 1NCT05049083
A Relative Bioavailability Study of Different Processes of SHR2554 Tablets in Healthy Adult Subjects
A Phase 1 study testing New Process SHR2554 tablet、Former Process SHR2554 tablet and Former Process SHR2554 tablet、New Process SHR2554 tablet in people with Lymphoma, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
TThe study is being conducted to evaluate the relative bioavailability, pharmacokinetics and safety of different tablet processes of SHR2554 in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Lymphoma
- What is being tested?
- New Process SHR2554 tablet、Former Process SHR2554 tablet and Former Process SHR2554 tablet、New Process SHR2554 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 17 Dec 2021to 29 Apr 2022
- 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
- Provision of written informed consent and willing and able to participate this research.
- Health female or male aged 18 to 45 at date of informed consent.
- Weighing ≥45 kg for female and ≥50 kg for male, body mass index between 19.0 and 26.0 kg/m2.
- Normal or abnormal but with no clinically significant in physical examination, vital signs, laboratory tests (haematology, clinical chemistry, urinalysis, coagulation function), 12 lead ECG, abdominal B ultrasound and CT.
- Participants should have no fertility plan and take effective contraceptive measures voluntarily from 2 weeks prior dose (for female) until 3 months after the last dose (for both female and male), and have no sperm or ovum donation plan; for fertile women the serum HCG test must be negative within Screening.
Who cannot join
- Participants with chronic or serious disease history or current disease in respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system, etc., and are not suitable for enrollment as assessed by the investigator.
- Surgery history that may affect drug absorption in gastrointestinal tract (including gastrectomy, enterectomy, stomach reduction surgery, etc.).
- Surgery history within 6 months prior to screening or surgery plans during the study.
- Plasma donation or blood loss greater than 400 mL or transfusion within 3 months prior to screening, or greater than 200 mL within 1 month prior to screening.
- Positive results on screening tests for HBsAg and/or HCsAg and/or HIV and/or syphilis.
- History of drug abuse or positive results of drug tests.
Show all 18Show fewer
- Alcohol abuse or smokers (≥14 units of alcohol per week within 6 months prior to screening: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine; ≥5 cigarettes per day), or unable to stop drinking or smoking during the study; positive results on screening tests for alcohol or nicotine.
- History of allergy/hypersensitivity (allergy/hypersensitivity to more than two substances), or are not suitable for enrollment as assessed by the investigator.
- Swallowing resistance or obstacles that affect drug absorption.
- Participation in any other clinical study that included drug treatment within 3 months prior to first SHR2554 dose.
- Administration of any CYP3A4 inducers or inhibitors within 4 weeks prior to first SHR2554 dose.
- Administration of any prescription/non-prescription medicine or traditional Chinese medicine or dietary supplement within 2 weeks prior to first SHR2554 dose.
- Administration of food or drinks that containing grapefruit, methylxanthine or alcohol within 72 hours prior to first SHR2554 dose; Strenuous exercise.
- Participants who have special dietary requirements and cannot accept a unified diet.
- Any factors that affect drug absorption, distribution, metabolism or excretion.
- Lactating women.
- History of fainting needles or blood; difficulty in blood collection or intolerance of venipuncture blood collection.
- Any factors are not suitable for enrollment as assessed by the investigator or participants withdrew from the study for their own reasons.
Trial locations and contacts
1 site in 1 country.
China1 site
the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
About this study
Official title: A Single-centre, Single-dose, Random, Open, Two-period, Cross-over Relative Bioavailability Study of Different Processes of SHR2554 Tablets in Healthy Adult Subjects
TThe study is being conducted to evaluate the relative bioavailability, pharmacokinetics and safety of different tablet processes of SHR2554 in healthy adult subjects.
- Conditions
- Lymphoma
- Being tested
- New Process SHR2554 tablet、Former Process SHR2554 tablet, Former Process SHR2554 tablet、New Process SHR2554 tablet
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Process SHR2554 tablet、Former Process SHR2554 tabletDrug
New Process, 350 mg SHR2554 tablets on study day 1 - Former Process, 350 mg SHR2554 tablets on study day 8
Former Process SHR2554 tablet、New Process SHR2554 tabletDrug
Former Process, 350 mg SHR2554 tablets on study day 1 - New Process, 350 mg SHR2554 tablets on study day 8
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Not described Receives: Drug: New Process SHR2554 tablet、Former Process SHR2554 tablet |
| Treatment group B | Experimental | Not described Receives: Drug: Former Process SHR2554 tablet、New Process SHR2554 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: day 1 to day 11
AUC0-t
Measured: day 1 to day 11
AUC0-∞
Measured: day 1 to day 11
Tmax
Measured: day 1 to day 11
t1/2
Measured: day 1 to day 11
CL/F
Measured: day 1 to day 11
Vz/F
Measured: day 1 to day 11
Secondary outcomes (1)
The incidence and severity of adverse events/serious adverse events
Measured: from ICF signing date to approximate day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start17 Dec 2021
- Primary completion6 Jan 2022 (estimated)
- Study completion29 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies 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
- Model description
- A single-centre, single-dose, random, open, two-period, cross-over relative bioavailability study.
- Masking
- None (open label)
- Enrolment
- 28 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
- NCT05049083
- Sponsor's protocol ID
- SHR2554-I-108
- Status last verified
- Dec 2021
- First submitted
- 9 Sep 2021
- Last updated
- 14 Jan 2022
- 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 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Single-dose, Random, Open, Two-period, Cross-over Relative Bioavailability Study of Different Processes of SHR2554 Tablets in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05049083
- Acronym / sponsor ID
- SHR2554-I-108
- Conditions
- Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 6 Jan 2022 (estimated)
- Study completion
- 29 Apr 2022 (estimated)
- First posted
- 17 Sep 2021 (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.
TThe study is being conducted to evaluate the relative bioavailability, pharmacokinetics and safety of different tablet processes of SHR2554 in healthy adult subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A single-centre, single-dose, random, open, two-period, cross-over relative bioavailability study.
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: New Process SHR2554 tablet、Former Process SHR2554 tablet |
| Treatment group B | Experimental | Drug: Former Process SHR2554 tablet、New Process SHR2554 tablet |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Provision of written informed consent and willing and able to participate this research.
- Health female or male aged 18 to 45 at date of informed consent.
- Weighing ≥45 kg for female and ≥50 kg for male, body mass index between 19.0 and 26.0 kg/m2.
- Normal or abnormal but with no clinically significant in physical examination, vital signs, laboratory tests (haematology, clinical chemistry, urinalysis, coagulation function), 12 lead ECG, abdominal B ultrasound and CT.
- Participants should have no fertility plan and take effective contraceptive measures voluntarily from 2 weeks prior dose (for female) until 3 months after the last dose (for both female and male), and have no sperm or ovum donation plan; for fertile women the serum HCG test must be negative within Screening.
Key exclusion criteria (18 listed)
- Participants with chronic or serious disease history or current disease in respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system, etc., and are not suitable for enrollment as assessed by the investigator.
- Surgery history that may affect drug absorption in gastrointestinal tract (including gastrectomy, enterectomy, stomach reduction surgery, etc.).
- Surgery history within 6 months prior to screening or surgery plans during the study.
- Plasma donation or blood loss greater than 400 mL or transfusion within 3 months prior to screening, or greater than 200 mL within 1 month prior to screening.
- Positive results on screening tests for HBsAg and/or HCsAg and/or HIV and/or syphilis.
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 |
|---|---|---|
| New Process SHR2554 tablet、Former Process SHR2554 tabletNew Process, 350 mg SHR2554 tablets on study day 1 - Former Process, 350 mg SHR2554 tablets on study day 8 | Drug | Treatment group A |
| Former Process SHR2554 tablet、New Process SHR2554 tabletFormer Process, 350 mg SHR2554 tablets on study day 1 - New Process, 350 mg SHR2554 tablets on study day 8 | Drug | Treatment group B |
Primary outcome
Cmax
Time frame: day 1 to day 11
AUC0-t
Time frame: day 1 to day 11
AUC0-∞
Time frame: day 1 to day 11
Tmax
Time frame: day 1 to day 11
t1/2
Time frame: day 1 to day 11
CL/F
Time frame: day 1 to day 11
Vz/F
Time frame: day 1 to day 11
1 secondary outcome
The incidence and severity of adverse events/serious adverse events
Time frame: from ICF signing date to approximate day 15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- 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 New Process SHR2554 tablet、Former Process SHR2554 tablet and Former Process SHR2554 tablet、New Process SHR2554 tablet in people with Lymphoma, 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: status not confirmed, as of the sponsor's last update on 14 Jan 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?
Results are not available in the source record.
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?
Cmax (time frame: day 1 to day 11). The study lists 7 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 14 Jan 2022; AzTrials last refreshed its copy on 6 Nov 2026.