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Status unknownNCT05049083Updated Jan 14, 2022

A Relative Bioavailability Study of Different Processes of SHR2554 Tablets in Healthy Adult Subjects

A Phase 1 interventional study of New Process SHR2554 tablet、Former Process SHR2554 tablet and Former Process SHR2554 tablet、New Process SHR2554 tablet in Lymphoma, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-14.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

TThe study is being conducted to evaluate the relative bioavailability, pharmacokinetics and safety of different tablet processes of SHR2554 in healthy adult subjects.

02

Conditions studied

  • Lymphoma
03

In context

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Provision of written informed consent and willing and able to participate this research.
  2. Health female or male aged 18 to 45 at date of informed consent.
  3. Weighing ≥45 kg for female and ≥50 kg for male, body mass index between 19.0 and 26.0 kg/m2.
  4. 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.
  5. 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.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Surgery history that may affect drug absorption in gastrointestinal tract (including gastrectomy, enterectomy, stomach reduction surgery, etc.).
  3. Surgery history within 6 months prior to screening or surgery plans during the study.
  4. 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.
  5. Positive results on screening tests for HBsAg and/or HCsAg and/or HIV and/or syphilis.
  6. History of drug abuse or positive results of drug tests.
  7. 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.
  8. History of allergy/hypersensitivity (allergy/hypersensitivity to more than two substances), or are not suitable for enrollment as assessed by the investigator.
  9. Swallowing resistance or obstacles that affect drug absorption.
  10. Participation in any other clinical study that included drug treatment within 3 months prior to first SHR2554 dose.
  11. Administration of any CYP3A4 inducers or inhibitors within 4 weeks prior to first SHR2554 dose.
  12. Administration of any prescription/non-prescription medicine or traditional Chinese medicine or dietary supplement within 2 weeks prior to first SHR2554 dose.
  13. Administration of food or drinks that containing grapefruit, methylxanthine or alcohol within 72 hours prior to first SHR2554 dose; Strenuous exercise.
  14. Participants who have special dietary requirements and cannot accept a unified diet.
  15. Any factors that affect drug absorption, distribution, metabolism or excretion.
  16. Lactating women.
  17. History of fainting needles or blood; difficulty in blood collection or intolerance of venipuncture blood collection.
  18. Any factors are not suitable for enrollment as assessed by the investigator or participants withdrew from the study for their own reasons.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Treatment group A

    Drug: New Process SHR2554 tablet、Former Process SHR2554 tablet

  • Experimental
    Treatment group B

    Drug: Former Process SHR2554 tablet、New Process SHR2554 tablet

Interventions

  • DrugNew Process SHR2554 tablet、Former Process SHR2554 tablet

    New Process, 350 mg SHR2554 tablets on study day 1 - Former Process, 350 mg SHR2554 tablets on study day 8

  • DrugFormer Process SHR2554 tablet、New Process SHR2554 tablet

    Former Process, 350 mg SHR2554 tablets on study day 1 - New Process, 350 mg SHR2554 tablets on study day 8

06

What researchers measure

Primary outcomes

  1. Cmax

    Time frame: day 1 to day 11

  2. AUC0-t

    Time frame: day 1 to day 11

  3. AUC0-∞

    Time frame: day 1 to day 11

  4. Tmax

    Time frame: day 1 to day 11

  5. t1/2

    Time frame: day 1 to day 11

  6. CL/F

    Time frame: day 1 to day 11

  7. Vz/F

    Time frame: day 1 to day 11

Secondary outcomes

  1. The incidence and severity of adverse events/serious adverse events

    Time frame: from ICF signing date to approximate day 15

07

Study locations

1 site
  • the Affiliated Hospital of Nanjing University Medical School
    Nanjing, Jiangsu 210008, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05049083
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Sep 17, 2021
Start date
Dec 17, 2021
Primary completion
Jan 6, 2022 (estimated)
Completion
Apr 29, 2022 (estimated)
Last update
Jan 14, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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