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

NCT05047341 | Completed Phase 1

• 1 other identifier: SHR0302-107
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rheumatoid Arthritis (RA)

Outcome Measures

Primary Outcomes (7)

• Cmax

  day 1 to day 11

• AUC0-t

  day 1 to day 11

• AUC0-∞

  day 1 to day 11

• Tmax

  day 1 to day 11

• t1/2

  day 1 to day 11

• CL/F

  day 1 to day 11

• Vz/F

  day 1 to day 11

Secondary Outcomes (1)

• The incidence and severity of adverse events/serious adverse events

  from ICF signing date to approximate day 11

Study Arms (1)

Single arm

EXPERIMENTAL

Drug: SHR0302、[14C]SHR0302

Interventions

SHR0302、[14C]SHR0302 DRUG

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

Single arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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：
• 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：

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

the first affiliated hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single-arm and open-label drug interaction study.

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 17, 2021
• Study Start: September 7, 2021
• Primary Completion: September 19, 2021
• Study Completion: June 8, 2022
• Last Updated: July 1, 2022

Record last verified: 2022-06

Locations

CN (1)