First-in-human single-dose ABCL575 test in healthy adults

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

This will give single increasing doses of ABCL575 or placebo to healthy adults to see if the drug is safe and well tolerated.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: AbCellera Biologics Inc. (Industry-sponsored)
• Locations: 1 site (Mount Royal, Quebec)
• Trial ID: NCT07108894 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled single ascending dose study will enroll healthy adult volunteers to receive either ABCL575 or placebo. The design includes five sequential cohorts (A1–A5) with eight participants per cohort and planned dose escalation between cohorts. Participants will be closely monitored for safety and tolerability with vital signs, ECGs, laboratory tests, and scheduled follow-up visits. The study aims to identify tolerable dose levels and any immediate adverse effects before further clinical testing.

Who should consider this trial

Good fit: Healthy adults aged 18–65 with BMI 18.5–30 and body weight 50–100 kg who are non- or ex-smokers and agree to contraception and not donating gametes are ideal candidates.

Not a fit: People who are pregnant or breastfeeding, have a resting seated pulse under 50 bpm, or who are seeking treatment for a medical condition would not be expected to gain clinical benefit from participation.

Why it matters

Potential benefit: If successful, the study could show that ABCL575 is safe enough to proceed to patient trials and help select appropriate doses for future studies.

How similar studies have performed: This is a first-in-human SAD for ABCL575; while SAD designs are commonly used to establish initial safety, this specific molecule has not been previously tested in people.

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 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, that in the opinion of an investigator would put into question the participant's healthy status.
* Use of any over-the-counter products in the 7 days or 5 half-lives (whichever is longer) 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.
* History of herpes zoster (shingles) or RZV (eg, Shingrix) vaccination within 28 days prior to screening or scheduled during the study period

Where this trial is running

Mount Royal, Quebec

• Altasciences Company Inc. — Mount Royal, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: Eric Sicard — Altasciences Company Inc.
• Study coordinator: Clinical Trial Coordinator

Conditions Healthy Volunteers