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

Not Applicable

Recruiting

• Conditions: Healthy Volunteers
• Interventions: Biological: ABCL575; Biological: Placebo (Normal Saline 0.9%)

• Registration Number: NCT07108894
• Lead Sponsor: AbCellera Biologics Inc.

Brief Summary

This study aims to assess the safety and tolerability of ABCL575 in healthy participants following single ascending dose (SAD), in comparison to a placebo

Detailed 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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-24
• Study Start: 2025-07-25
• Study First Submitted QC: 2025-08-05
• Study First Posted: 2025-08-07
• Last Update Submitted: 2025-08-12
• Last Update Posted: 2025-08-15
• Primary Completion: 2026-11
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABCL575	ABCL575	Healthy participants will receive a single dose of ABCL575 administered by subcutaneous (SC) injection
Placebo	Placebo (Normal Saline 0.9%)	Healthy participants will receive a single dose of placebo administered by subcutaneous (SC) injection

Primary Outcome Measures

Name	Time	Method
Incidence, frequency, and severity of adverse events (AEs)	Day 0 to day 337
Changes from baseline in physical examination	Day 0 to day 337
Changes from baseline in vital signs	Day 0 to day 337
Changes from baseline in laboratory parameters including general biochemistry, lipid profile, coagulation, hematology, and urinalysis	Day 0 to day 337
Changes from baseline in 12-lead safety ECGs	Day 0 to day 337
Incidence and severity of injection site reactions	Day 0 to day 337

Secondary Outcome Measures

Name	Time	Method
Plasma concentrations of ABCL575	Day 0 to day 337
Incidence of anti-ABCL575 antibodies	Day 0 to day 337
PK parameters; maximum plasma concentration (Cmax)	Day 0 to day 337
PK parameters; time to maximum plasma concentration (Tmax)	Day 0 to day 337
PK parameters; area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration (AUC0-T)	Day 0 to day 337
PK parameters; area under the plasma concentration-time curve from zero to hour 672 (AUC0-672)	Day 0 to day 337
PK parameters; area under the plasma concentration-time curve from zero to infinity (AUC0-∞)	Day 0 to day 337
PK parameters; terminal rate constant (λz)	Day 0 to day 337
PK parameters; apparent plasma clearance of drug after extravascular administration (CL/F)	Day 0 to day 337
PK parameters; apparent volume of distribution after extravascular administration (Vz/F)	Day 0 to day 337
PK parameters; half-life (Thalf)	Day 0 to day 337

Trial Locations

Locations (1)

Altasciences Company Inc.; 🇨🇦 Mont-Royal, Quebec, Canada