Overview
This clinical trial is the first-in-human study of Kylo-0603. The purpose of this randomized, double-blind, placebo-controlled phase 1 study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and effect of food of Kylo-0603 in healthy Chinese adult subjects.
Description
The study consists of three parts: single ascending doses (Part 1), food effect (Part 2) and multiple ascending doses (Part 3).
Eligibility
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;
- Having no clinically significant disorder, condition or disease at screening and before first dosing;
- 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 of cardiovascular, respiratory, digestive, liver, urinary, hematological, endocrine, metabolic, immune, cutaneous, or psychoneurotic diseases;
- 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 tuberculosis 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;
- Pregnant or breast-feeding women;
- Other exclusion criteria applied per protocol.