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

NCT07108894 | Recruiting Phase 1

• 2 other identifiers: ABCL575-101297628
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (6)

• Incidence, frequency, and severity of adverse events (AEs)

  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 physical examination

  Day 0 to day 337

• Changes from baseline in vital signs

  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 Outcomes (11)

• 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

Study Arms (2)

ABCL575

EXPERIMENTAL

Healthy participants will receive a single dose of ABCL575 administered by subcutaneous (SC) injection

Biological: ABCL575

Placebo

PLACEBO COMPARATOR

Healthy participants will receive a single dose of placebo administered by subcutaneous (SC) injection

Biological: Placebo (Normal Saline 0.9%)

Interventions

ABCL575 BIOLOGICAL

Participants will receive SC injection of ABCL575

ABCL575

Placebo (Normal Saline 0.9%) BIOLOGICAL

Participants will receive SC injection of placebo (Normal Saline 0.9%)

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 the time of signing the ICF through the 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbCellera Biologics Inc.: lead

Study Sites (1)

Altasciences Company Inc.

Mount Royal, Quebec, H3P 3P1, Canada

RECRUITING

Study Officials

• Eric Sicard

  Altasciences Company Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trial Coordinator

CONTACT

1-877-933-9037; clinicaltrials@abcellera.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 7, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)