A First-in-Human Phase 1 Single-Ascending Dose Study of ABCL575 in Healthy Participants

Launched by ABCELLERA BIOLOGICS INC. · Aug 5, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new medicine called ABCL575 to see if it is safe and well-tolerated when given as a single dose to healthy adults. The study compares the effects of ABCL575 to a placebo (a harmless substance) to understand how the body reacts to the medicine. This is an early study, which means it’s the first time ABCL575 is being tested in people.

Adults between 18 and 65 years old who are generally healthy may be eligible to join. To participate, individuals need to have a body weight between 50 and 100 kilograms (about 110 to 220 pounds) and a body mass index (BMI) within a healthy range. Both men and women can join, but women who can have children must agree to use birth control during the study. People who are pregnant, have certain health conditions, or take other medications may not be able to participate. If you join the study, you will receive one dose of the medicine or a placebo and be closely monitored to check your safety and how your body responds. The study is currently recruiting volunteers, and the information gathered will help researchers understand if ABCL575 is safe for future studies.

Gender

ALL

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 at least 28 days prior to the screening visit through 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 than 100 bpm or a seated blood pressure \< 90/50 mmHg or \> 140/90 mmHg
• • eGFR \< 60 mL/min/1.73 m2
• • Severe hypersensitivity reactions (like angioedema) to any drugs.
• • Presence or history of significant gastrointestinal, liver disease, kidney disease, or surgery that may affect drug bioavailability.
• • History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic, or dermatologic disease.
• • History or presence of multiple or severe drug allergies.
• • Evidence of any active bacterial, viral, or fungal infection
• • Disrupted skin integrity (apparent burn or dermatitis).
• • History of syncope, palpitations, or unexplained dizziness.
• • Use of prescription drugs (except for hormonal contraceptives or hormone replacement therapy) in the 28 days prior to study drug administration.
• • Use of any over-the-counter products in the 7 days prior to study drug administration.
• • Receipt of live vaccines within 5 weeks prior to screening or plans to receive live vaccines within 180 days after study drug administration.
• • History of latent or active tuberculosis.