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ADME Study of [14C]-Jaktinib in Healthy Male Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

ADME Study of [14C]-Jaktinib in Healthy Male Subjects

Absorption, Distribution, Metabolism, and Excretion Study of [14C]-Jaktinib in Chinese Male Healthy Subjects(The Mass Balance and Biotransformation Study of [14C]-Jaktinib).

NCT05150717•Suzhou Zelgen Biopharmaceuticals Co.,Ltd

View on ClinicalTrials.gov

Summary

This study was designed to evaluate the mass balance and biotransformation after single-dose of \[14C\]-Jaktinib orally in Chinese healthy male subjects.

Eligibility

Age

18 - 45 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy Chinese males, aged 18-45 years old (inclusive);
•Body weight ≥ 50.0 kg, body mass index (BMI) between 19-26kg/m2 (inclusive);
•Sign the informed consent form；
•Participants are able to communicate well with the investigators and be able to complete the trial according to the Process.

Exclusion Criteria

•Physical examination, vital signs, routine laboratory tests, 12-lead ECG, Chest X-ray, abdominal B-ultrasound and other is abnormal and clinically significant;
•Positive for hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antibody, or Treponema pallidum antibodies;
•Use of any prescription or over-the-counter drug, any vitamin product, health care drug or Chinese herbal medicine within 14 days prior to screening.
•Participants who have participated in any clinical trials within 3 months prior to screening and have used the test drug or medical devices.
•A history of any clinically serious illness or condition, including but not limited to circulatory, endocrine, nervous,digestive, urinary, or blood, immune, mental, and metabolic diseases, that the investigator considers to be likely to affect the results of the study.
•Participants who had heart disease such as heart failure, angina pectoris, myocardial infarction, and clinically significant arrhythmia.
•Participants who had undergone major surgery or whose surgical incision was not completely healed within 6 months before the screening period; Major surgery includes, but is not limited to, any surgery with a significant risk of bleeding, prolonged general anesthesia, or an open biopsy or significant traumatic injury.
•Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before screening.
•Hemorrhoids or perianal diseases with regular/bleeding in the stool; Patients with gastrointestinal dysfunction, such as irritable bowel syndrome and inflammatory bowel disease, may be affected by drug absorption as determined by researchers.
•Habitual constipation or diarrhea.
+9 more criteria

Locations (1)

The First Affiliated Hospital of soochow University

Suzhou, Jiangsu, China

Key Dates

Start Date

January 4, 2022

Primary Completion Date

January 30, 2022

Completion Date

January 30, 2022

Last Updated

January 11, 2024

Enrollment

ACTUAL participants

Conditions

Healthy Adult Male Volunteers

Interventions

[14C]-Jaktinib

DRUG

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Healthy Adult Male Volunteers

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COMPLETEDPHASE1

Study to Evaluate the Mass Balance and Biotransformation of [14C]SHR4640 in Chinese Healthy Adult Male Volunteers.

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Healthy Adult Male Volunteers

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 11, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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