Phase 1 Study of LQT-1213 in Healthy Adults

A Phase 1, Randomized, Double-blinded, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluated the Safety, Tolerability, Pharmacokinetics, Food Effect, and Pharmacodynamics of LQT-1213 in Healthy Adult Participants

This is a single-center, randomized, double-blind, placebo-controlled study to be conducted in 2 parts: single ascending dose (SAD) incorporating a food effect arm and multiple ascending dose (MAD). Potential participants for each part will undergo screening procedures within 28 days of enrollment.

Key Inclusion Criteria:

• Healthy adult male or female participants
• Females of childbearing potential must agree and commit to use an adequate form of contraception.
• Men who are biologically capable of fathering children must agree and commit to use an adequate form of contraception.
• Aged at least 18 years but not older than 60 years (inclusive)
• Body mass index (BMI) within 18.0 kg/m^2 to 32.0 kg/m^2, inclusively.
• Non- or ex-smoker
• Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an investigator.

Exclusion Criteria:

• Clinically significant diseases or any other condition, which, in the opinion of the Investigator, would jeopardize the safety of the participant or impact the validity of the study results.
• Clinically significant abnormal findings on the physical examination or medical history during screening as deemed by the principal investigator
• Female who is lactating
• Female who is pregnant
• Male participants with a history of oligospermia or azoospermia or any other disorder of the reproductive system
• Male participants who are undergoing treatment or evaluation for infertility.
• History of significant hypersensitivity to LQT-1213, kinase inhibitors or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
• Use of immunosuppressant in the 28 days prior to the first study drug administration
• Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
• Intake of an investigational product or participation in a clinical trial in the 90 days prior to the first study drug administration