Actively Recruiting
A First-in-Human Phase 1 Single-Ascending Dose Study of ABCL575 in Healthy Participants
Led by AbCellera Biologics Inc. · Updated on 2026-03-23
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of ABCL575, a biological agent, in healthy adult volunteers aged 18 to 65 years. This phase 1, randomized, double-blind, placebo-controlled study focuses on single ascending doses (SAD) of ABCL575 compared to placebo to understand how the body reacts to increasing doses and to monitor any side effects. The study is sponsored by AbCellera Biologics Inc. and involves healthy participants without significant health issues. Participants will be assigned randomly to one of five groups (cohorts A1 to A5) receiving escalating single doses of ABCL575 or placebo via subcutaneous injection. Each cohort includes eight healthy participants who receive either the study drug or a placebo injection. The dosing escalates from cohort A1 to A5 to gradually assess safety at higher doses. Throughout the study, participants will be monitored from day 0 up to day 337. Assessments include tracking adverse events, changes in laboratory tests (such as blood chemistry, lipids, coagulation, and urinalysis), vital signs, physical exams, ECGs, and injection site reactions. The study will also measure how ABCL575 is processed in the body, including blood levels over time and immune responses to the drug. Participants will undergo regular safety checks and evaluations during this period.
CONDITIONS
Brief Title
A First-in-Human Phase 1 Single-Ascending Dose Study of ABCL575 in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male or female 18 to 65 years of age at screening
- Good general health confirmed by medical history and physical exam
- Body weight between 50 and 100 kilograms
- Body mass index (BMI) between 18.5 and 30.0 kg/m2
- Non-smoker or ex-smoker (stopped nicotine use at least 180 days before drug administration)
- Either of childbearing potential agreeing to use contraception, or of nonchildbearing potential
- If male, agrees not to donate sperm during the study; if female, agrees not to donate or retrieve eggs during the study
You will not qualify if you...
- Pregnancy or breastfeeding
- Seated pulse rate less than 50 or greater than 100 beats per minute
- Seated blood pressure less than 90/50 mmHg or greater than 140/90 mmHg
- Estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m2
- Severe allergic reactions to any drugs
- Significant gastrointestinal, liver, kidney disease, or related surgeries impacting drug absorption
- History of serious cardiovascular, pulmonary, blood, neurological, psychiatric, endocrine, immune, or skin diseases
- Multiple or severe drug allergies
- Active bacterial, viral, or fungal infections
- Skin problems such as burns or dermatitis
- History of fainting, palpitations, or unexplained dizziness
- Use of prescription drugs (except hormonal contraceptives or hormone therapy) within 28 days before drug administration
- Use of over-the-counter products within 7 days or 5 half-lives before drug administration
- Receipt of live vaccines within 5 weeks before screening or planned within 180 days after drug administration
- History of latent or active tuberculosis
- History of shingles or shingles vaccination within 28 days before screening or planned during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single dose on Day 0
Participants receive a single subcutaneous injection of ABCL575 or placebo as part of the study dosing.
1 dosing visit (in-person) and multiple follow-up visits up to Day 337
Duration - Up to 337 days after dosing
Participants are monitored for safety, laboratory changes, and drug levels after dosing.
Multiple visits for safety and pharmacokinetic assessments up to Day 337
Trial Site Locations
Total: 1 location
1
Altasciences Company Inc.
Mount Royal, Quebec, Canada, H3P 3P1
Actively Recruiting
Research Team
C
Clinical Trial Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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