A First-in-Human Phase 1 Single-Ascending Dose Study of ABCL575 in Healthy Participants
Trial Parameters
Brief Summary
This study aims to assess the safety and tolerability of ABCL575 in healthy participants following single ascending dose (SAD), in comparison to a placebo
Eligibility Criteria
Inclusion Criteria: * Healthy male or female ≥ 18 and ≤ 65 years of age at the time of screening * Good general health as determined through medical history and general physical examination * Body weight ≥ 50 and ≤ 100 Kg * Body mass index (BMI) between 18.5 kg/m2 and 30.0 kg/m2 * Non- or ex-smoker (an ex-smoker defined as someone who has completely stopped using nicotine products for at least 180 days prior to study drug administration) * Meeting 1 of the following: 1. Is of childbearing potential or able to procreate and agrees to use an acceptable contraceptive method from the time of signing the ICF through the EOS visit. 2. Is of nonchildbearing potential or unable to procreate * If male, agrees not to donate sperm from the study drug administration through EOS visit; If female, agrees not to donate or retrieve eggs from the study drug administration through EOS visit Exclusion Criteria: * Pregnancy and/or lactation. * Seated pulse rate less than 50 beats per minute (bpm) or more