A Mass Balance Study of [14C]ABSK011

Launched by ABBISKO THERAPEUTICS CO, LTD · Mar 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called [14C]ABSK011 to understand how it is absorbed, processed, and eliminated by the body in healthy adult males. The researchers will enroll 6 to 8 healthy men between the ages of 18 and 45 to take a single dose of the drug. By doing this, they hope to gather important information about how the drug behaves in the body.

To participate, men must be in good health, weigh at least 50 kg, and have a body mass index (BMI) between 19 and 26. They should also have regular bowel movements and agree to use effective contraception during the study and for six months afterward. Participants will undergo several health checks to ensure they qualify and to monitor their safety throughout the trial. This study is currently not recruiting participants, but it aims to provide valuable insights into the drug’s safety and effectiveness.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Participants who fully understand the content, procedures and possible adverse reactions before the study, and voluntarily sign the informed consent form, and can complete the study in accordance with the requirements in the protocol;
• • 2. Healthy male participants aged 18 to 45 years (including 18 and 45 years) at screening;
• • 3. Weight ≥ 50 kg, body mass index (BMI) between 19 and 26 (including 19 and 26), BMI = weight (kg)/height (m) \^2;
• • 4. Participants must have regular defecation in the past three months;
• • 5. Male participants of childbearing potential must agree to use effective contraceptive methods during the study and within 6 months after administration of study drug . Male subjects must agree to not donate sperm during this period.
• Exclusion Criteria:
• • 1. Abnormal and clinically significant complete physical examination, vital signs, digital rectal examination, laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function, stool routine + occult blood, thyroid function, etc.), 12-lead electrocardiogram, chest X-ray (anteroposterior position), abdominal B ultrasound (hepatobiliary, pancreas, spleen and kidney);
• • 2. Tested positive for any one of the following: serum hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antigen/antibody, treponema pallidum antibody (Syphilis) screening;
• • 3. The baseline of heart rate corrected QT, QTcF interval prolongs ≥450ms; family history of long QT syndrome (Note: QTc interval is corrected by Fridericia formula);
• • 4. Known or persistent mental disorders that may interfere with the subject's participation in the study, as judged by the investigator;
• • 5. Known history of allergy to any drug or food;
• • 6. Participants who have participated in drug trials within 3 months before dosing.
• • 7. Participants who have participated in this study or any other study related to ABSK011, and have previously exposed to ABSK011;
• • 8. Known history of drug abuse or tested positive in drug abuse screening;
• • 9. Participants with any other factors that may influence the participation in the study, which may affect the subject's compliance with the protocol, interfere with the interpretation of the study results, or expose the subject to risk, as judged by the investigator.