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

Last updated: August 8, 2025
Sponsor: AbCellera Biologics Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

ABCL575

Placebo (Normal Saline 0.9%)

Clinical Study ID

NCT07108894
ABCL575-101
297628
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study aims to assess the safety and tolerability of ABL575 in healthy participants following single-dose administration (SAD), in comparison to a placebo

Eligibility Criteria

Inclusion

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 physicalexamination

  • 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 usingnicotine 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 anacceptable contraceptive method from at least 28 days prior to the screeningvisit 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 EOSvisit; If female, agrees not to donate or retrieve eggs from the study drugadministration through EOS visit

Exclusion

Exclusion Criteria:

  • Pregnancy and/or lactation.

  • Seated pulse rate less than 50 beats per minute (bpm) or more than 100 bpm or aseated 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 replacementtherapy) in the 28 days prior to study drug administration.

  • Use of any over-the-counter products in the 7 days prior to study drugadministration.

  • Receipt of live vaccines within 5 weeks prior to screening or plans to receive livevaccines within 180 days after study drug administration.

  • History of latent or active tuberculosis.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: ABCL575
Phase: 1
Study Start date:
July 25, 2025
Estimated Completion Date:
November 30, 2026

Study 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.

Connect with a study center

  • Altasciences Company Inc.

    Mont-Royal, Quebec H3P 3P1
    Canada

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.