Overview
This study aims to assess the safety and tolerability of ABCL575 in healthy participants following single ascending dose (SAD), in comparison to a placebo
Description
This is a phase I randomized, double-blind, placebo-controlled, single ascending dose (SAD) study. The study will consist of 4 planned cohorts (A1 to A4), each comprised of 8 healthy participants. Doses of ABCL575 are intended to escalate through cohorts A1 to A4.
Eligibility
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:
- 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
- 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.