Study of [14C]CS0159 in China Healthy Subjects

• Status: Completed
• Trial end date: 2023-11-02
• Target enrollment: 0
• Participant gender: Male

Summary

Study of [14C]CS0159 in China Healthy Subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cascade Pharmaceuticals, Inc

Criteria

Inclusion Criteria:

1. Healthy male subjects between the ages of 18 and 45 years (inclusive).

2. Subjects should not weigh less than 50 kg, BMI between 19~26 kg/㎡.

3. No sperm donation or fertility plan during the study and within 12 months after the end of the study.

4. Understand the purpose and requirements of trial, subjects who have voluntarily participated in the study and signed the ICF, completion of tests as required.

Exclusion Criteria:

1. With abnormal and clinically significant comprehensive physical examinations, vital signs,laboratory examinations, 12-ECG, chest X-ray, and abdominal ultrasound.

2. 12-ECG QT(QTcF)>450ms.

3. The history of drug allergy.

4. Patients with malabsorption and gastrointestinal disorders or history of Vomiting, diarrhoea in the week prior to the screening period.

5. Patients with difficulty swallowing or interfere with drug absorption.

6. HBs Ag or E antigen, TPAb, or HIV-Ag/Ab positive person.

7. Have taken any clinical trial medication or participated in any other clinical trial within 3 months prior to the screening period.

8. Habitual constipation or diarrhoea.

9. Heavy smokers addicts

10. Heavy drinker addicts.

11. Has drug abuse history or positive drug abuse test results.

12. Heavy caffeine addicts.

13. Special dietary requirements.

14. Poor adherence or any other conditions judged by the investigator as not suitable for the study.