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Rheumatoid Arthritis (RA)Phase 1NCT05047341

A Study of Human Substance Balance and Biotransformation of [14C]SHR0302

A Phase 1 study testing SHR0302、[14C]SHR0302 in people with Rheumatoid Arthritis (RA), 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 study is being conducted to evaluate the absorption, metabolism and excretion of [14C]SHR0302 in healthy Chinese adult male subjects. 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
Rheumatoid Arthritis (RA)
What is being tested?
SHR0302、[14C]SHR0302
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteChina
Study dates
7 Sep 2021to 8 Jun 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
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Voluntarily sign the informed consent form, communicate well with the investigator and be able to complete the trial in strict compliance with the protocol;
  • Chinese male subjects judged by the investigator to be healthy;
  • Adults aged 18 to 45 years (including both ends of the spectrum, as at the time of signing the informed consent form);
  • Weight ≥ 50 kg and a body mass index (BMI) in the range of 19 to 26 kg/m2 (both ends inclusive).

Who cannot join

  • Ancillary examinations :
  • Abnormalities in physical examination, vital signs, routine laboratory tests (complete blood cell analysis, blood biochemistry, coagulation, urine routine, stool routine + occult blood), thyroid function, 12-lead ECG, chest CT, abdominal ultrasound (liver, gallbladder, pancreas, spleen and kidney) and other tests of clinical significance.
  • Resting corrected QT interval (QTcF) >450 ms obtained on a 12-lead ECG.
  • Positive for hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antibody and syphilis antibody.
  • Screening for novel coronavirus infection with clinically significant abnormal C-reactive protein or positive novel coronavirus nucleic acid.
  • Medication history：
Show all 28Show fewer
  • Systemic use of any drug that inhibits or induces CYP3A within 30 days prior to the screening period (e.g., inducers - bosentan, paracetamol, efavirenz, etravirine, phenobarbital, rifampin, mitotane, phenytoin sodium, carbamazepine, apatamide, etc.; inhibitors - -erythromycin, clarithromycin, fluconazole, ketoconazole, itraconazole, posaconazole, voriconazole, ciprofloxacin, diltiazem, fluvoxamine, nelfinavir, conivaptan, aripitant, crizotinib, imatinib, dronedarone, cyclosporine).
  • Have used any prescription drugs, over-the-counter medicines, herbal remedies or dietary supplements such as vitamins, calcium supplements within 14 days prior to the screening period.
  • Medical and surgery history：
  • History of any clinically significant illness or disease or condition that, in the opinion of the investigator, may affect the results of the test, including but not limited to circulatory, respiratory, endocrine, neurological, digestive, urinary or haematological, immunological, psychiatric and metabolic disorders.
  • History of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmias, torsional ventricular tachycardia, ventricular tachycardia, atrioventricular block, QT prolongation syndrome or symptoms of QT prolongation syndrome and family history (indicated by genetic evidence or sudden death of a close relative at a young age due to cardiac causes).
  • Have undergone major surgery within the 6 months prior to the screening period or where the surgical incision has not fully healed; major surgery includes, but is not limited to, any surgery with significant risk of bleeding, extended general anaesthesia, or incisional biopsy or significant traumatic injury.
  • Allergies, such as a known history of allergy to two or more substances; or a potential allergy to the test drug or its excipients as judged by the investigator.
  • Haemorrhoids or perianal disease with regular/ongoing blood in the stool, irritable bowel syndrome, inflammatory bowel disease.
  • Living habits：
  • Habitual constipation or diarrhoea.
  • Alcohol abuse or regular alcohol consumption within the 6 months prior to the screening period, i.e. more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits at 40% alcohol by volume or 150 mL of wine); or an alcohol breath test result of ≥20 mg/dL at the screening period.
  • Those who smoked more than 5 cigarettes per day or habitually used nicotine-containing products in the 3 months prior to the screening period and were unable to quit during the trial.
  • Substance abuse or use of soft drugs (e.g. cannabis) 3 months prior to the screening period or hard drugs (e.g. cocaine, amphetamines, phencyclidine, etc.) 1 year prior to the screening period; or a positive urine drug test during the screening period.
  • Habitual consumption of grapefruit juice or excessive amounts of tea, coffee and/or caffeinated beverages that cannot be abstained from during the trial.
  • Others：
  • Workers exposed to prolonged radiological conditions; or who have had significant radiological exposure (≥2 chest/abdominal CTs, or ≥3 other types of X-ray examinations) or participated in radiopharmaceutical labelling tests within 1 year prior to the test.
  • People who have a history of needle sickness or blood sickness, have difficulty collecting blood or cannot tolerate venipuncture blood collection.
  • Participation in any other clinical trial (including clinical trials such as drugs and devices) within 3 months prior to the screening period.
  • Those who have been vaccinated within 1 month prior to screening or those who are scheduled to be vaccinated during the trial period.
  • Those who plan to have children or donate sperm during the trial and within 1 year after completion of the trial, or who do not agree that subjects and their spouses should use strict contraception during the trial and within 1 year after completion of the trial (see Annex 1 for details).
  • Those who have lost or donated up to 400 mL of blood within 3 months prior to the screening period, or those who have received a blood transfusion within 1 month.
  • Subjects who, in the opinion of the investigator, have any factors that make them unsuitable for this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • the first affiliated hospital of Soochow University

    Suzhou, Jiangsu, 215006

Other trials in China

About this study

Official title: A Clinical Trial of the Absorption, Metabolism and Excretion of [14C]SHR0302 in Healthy Chinese Adult Male Subjects

The study is being conducted to evaluate the absorption, metabolism and excretion of [14C]SHR0302 in healthy Chinese adult male subjects.

Being tested
SHR0302、[14C]SHR0302
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • SHR0302、[14C]SHR0302Drug

    8 mg SHR0302/ 80 µCi [14C]SHR0302, once, D1

Study groups in NCT05047341
Study groupRoleWhat they receive
Single armExperimentalNot described
Receives: Drug: SHR0302、[14C]SHR0302

What is being measured

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

  1. Cmax

    Measured: day 1 to day 11

  2. AUC0-t

    Measured: day 1 to day 11

  3. AUC0-∞

    Measured: day 1 to day 11

  4. Tmax

    Measured: day 1 to day 11

  5. t1/2

    Measured: day 1 to day 11

  6. CL/F

    Measured: day 1 to day 11

  7. Vz/F

    Measured: day 1 to day 11

Secondary outcomes (1)

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

    Measured: from ICF signing date to approximate day 11

Timeline

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

  1. First posted17 Sep 2021
  2. Study start7 Sep 2021
  3. Primary completion19 Sep 2021
  4. Study completion8 Jun 2022

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
This is a single-arm and open-label drug interaction study.
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05047341
Sponsor's protocol ID
SHR0302-107
Status last verified
Jun 2022
First submitted
8 Sep 2021
Last updated
1 Jul 2022
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、[14C]SHR0302 in people with Rheumatoid Arthritis (RA), 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 28 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 1 Jul 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?

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?

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?

On the ClinicalTrials.gov record for NCT05047341.

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 1 Jul 2022.

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