Single-ascending Dose Study of Kylo-12 in Healthy Subjects

Launched by KYLONOVA (XIAMEN) BIOPHARMA CO., LTD. · Jan 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called Kylo-12, which is being tested for its effects on a condition known as hypertriglyceridemia, where levels of fats called triglycerides in the blood are too high. This is the first time Kylo-12 will be given to people, and the trial will involve about 50 healthy volunteers. Participants will receive either the medication or a placebo (a harmless pill with no active ingredients) to see how safe it is and how it works in the body.

To be eligible for this study, participants need to be men or women aged 18 to 55, have a body mass index (BMI) between 19 and 30, and have elevated triglyceride levels as defined by the study. Women must not be able to become pregnant, and men must follow specific contraception guidelines. Participants can expect to visit the study site for assessments and provide their consent to be part of the trial. It's important to note that individuals with certain health conditions, recent drug use, or those who are pregnant or breastfeeding cannot participate. This study is not yet recruiting participants, so interested individuals will need to wait for the enrollment to begin.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Men and women aged 18 to 55 years old, inclusive;
• • Body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive;
• • Protocol-defined elevated serum TG level;
• • Female subjects must not be able to get pregnant and male subjects must agree to adhere to contraception restrictions;
• • Willing to comply with protocol required visits and assessments, and provide written informed consent.
• Exclusion Criteria:
• • History or evidence of a clinically significant disorder, condition or disease;
• • Received an investigational drug, vaccine or device within 3 months before dosing;
• • History of evidence of malignant tumor or Gilbert syndrome;
• • Positive screen of Hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus or syphilis infection;
• • History of alcohol abuse within 12 months before dosing;
• • History of drug abuse within 3 months before screening;
• • History of blood donations or blood loss of 400 ml and more within 3 months before dosing;
• • History of stroke or myocardial infarction within 6 months before sceening;
• • Pregnant or breast-feeding women;
• • Other exclusion criteria applied per protocol.