Phase 1 Study of LQT-1213 in Healthy Adults

• Status: Completed
• Trial end date: 2023-03-05
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Thryv Therapeutics, Inc.

Criteria

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