Evaluate the Pharmacokinetics of BAT2606 Injection in Healthy Chinese Male Subjects

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

To evaluate the pharmacokinetics, safety and immunogenicity of BAT2606 in healthy China male subjects.

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

Details

• Lead Sponsor: Bio-Thera Solutions

Criteria

Inclusion Criteria:

• 1. Subjects have signed the informed consent before the trial, and fully understood the content, process and relevant risks of the trial.

• 2. Subjects who are able to complete the study in accordance with the requirements of the protocol.

• 3. Visiting subjects (including partners) who are willing to comply with the study provisions agree to have no pregnancy plans and no donor sperm plans throughout the trial and for 6 months after dosing, and to voluntarily use effective contraception, as described in Appendix 4.

• 4. Subjects with BMI between 18 and 28 kg/m2 (both inclusive) and body weight between 55 and 85 kg (both inclusive).

• 5. Healthy Chinese male subjects between the ages of 18 and 55 years (both inclusive).

• 6. Subjects with normal or abnormal physical examinations without clinical significance.

Exclusion Criteria:

• 1. Subjects who have clinically significant abnormalities in clinical laboratory tests.

• 2. Subjects with clinical significance of abnormal ECG, chest x-ray.

• 3. Subjects with history of hypertension.

• 4. Subject who are or had been suffering from malignant neoplasm; subject who are or had been suffering from inflammatory bowel disease.

• 5. Subjects who have an active infection within 2 months prior to screening, including acute and chronic infections as well as localized infections.

• 6. Subjects who have active tuberculosis.

• 7. Subjects who have been exposed to TB within 3 months prior to screening.

• 8. Subjects whose T-cell test for tuberculosis infection (T-SPOT.TB) results are positive.

• 9. Subjects who are positive for HBsAg on the hepatitis B half test.

• 10. Subjects who have had a major injury or undergone previous surgical procedures or fracture within 4 weeks prior to enrollment.

• 11. Subjects who have taken any prescription medication within 28 days prior to screening.

• 12. Subjects who participate in another drug clinical trial within 3 months prior to enrollment.

• 13. Subjects who suffered an acute illness from the screening period until study drug administration.

• 14. Subjects who have received Mepolizumab (or its biosimilar) within 6 months (or within 5 half-lives of the drug, whichever is longer) prior to screening.

• 15. Subjects who have received live vaccination during the study period within 12 weeks prior to study dosing.

• 16. Subjects who are suspected or confirmed to be allergic (allergic to multiple medications or foods).

• 17. Subjects who smoked more than 5 cigarettes per day in the 3 months prior to screening.

• 18. Subjects who have taken any alcohol-containing product within 24h prior to study dosing.

• 19. Subjects who have donated blood or lost a significant amount of blood (> 450 mL) within 3 months prior to study drug administration.

• 20. Subjects with a positive urine drug screening.

• 21. Subject who is deemed unsuitable for enrollment by the investigator.