This is a Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QLS1510 in Healthy participants
Male and female adults aged between 18 and 45 years, inclusive, at the time of informed consent,
Medically healthy with no clinically significant or relevant abnormalities in medical history, physical exam, vital signs, ECG, or laboratory evaluations as assessed by the Investigator,
Body weight ≥50 kg for males and ≥45 kg for females with a body mass index (BMI) between 18.0 and 26.0 kg/m2,
Participants (including their partners) confirm they have no plans to donate sperm or egg, undergo in vitro fertilization (IVF), or become pregnant, and they agree to use highly effective contraceptive methods.
Participants with any disease identified at screening that warrants exclusion in the Investigator's judgment,
Participants with a history of severe allergic reactions (e.g., angioedema or anaphylactic shock), atopic diathesis (e.g., pollen allergy, allergy to two or more drugs or foods), and/or known hypersensitivity to the IP or any of its components,
Participants with functional asplenia, history of splenectomy, or prior exposure to immunosuppressive therapies or agents, or any other condition that, in the investigator's judgment, compromises immune function,
Participants with positive test results for hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb) and detectable hepatitis B virus deoxyribonucleic acid (HBV-DNA), or positive hepatitis C virus antibody (HCVAb), Treponema pallidum-specific antibody, or human immunodeficiency virus (HIV) antibody during the screening period,