A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GNS-3545 in Healthy Participants

Inclusion Criteria: * Healthy, adult, male or female (of non-childbearing potential only), 18-55 years of age * Male subjects must follow protocol specified contraception guidance * Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing * BMI ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit and body weight of ≥ 50 kg * Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, or vital signs, as deemed by the PI or designee * No ECG findings of clinical significance as judged by the PI or qualified designee * Understands the study procedures in the ICF and be willing and able to comply with the protocol Exclusion Criteria: * Is mentally or legally incapacitated or has significant emotional problems * History or presence of clinically significant medical or psychiatric conditions * History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study * Surgical procedure or Administration of a live vaccination within 30 days prior to the first dose of the study drug * History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing * History or presence of hepatic impairment * History or presence of significant cardiovascular conditions or risk factors * Subjects with a higher risk of adverse events in the setting of blood …