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ABCL575

Phase 1

Healthy Volunteers | Monoclonal antibody | Other |AbCellera Biologics Inc.|Last Updated: Jun 16, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

ABCL575 · 1 trial · 1 indication

Phase 1 1
NCT07108894A First-in-Human Phase 1 Single-Ascending Dose Study of ABCL575 in Healthy ParticipantsHealthy Volunteers
ACTIVE NOT_RECRUITING40 Analytics
PHASE1ACTIVE NOT_RECRUITING
A First-in-Human Phase 1 Single-Ascending Dose Study of ABCL575 in Healthy Participants
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ABCL575EXPERIMENTALHealthy participants will receive a single dose of ABCL575 administered by subcutaneous (SC) injection
PlaceboPLACEBO_COMPARATORHealthy participants will receive a single dose of placebo administered by subcutaneous (SC) injection

Interventions

NameTypeDescription
ABCL575BIOLOGICALParticipants will receive SC injection of ABCL575
Placebo (Normal Saline 0.9%)BIOLOGICALParticipants will receive SC injection of placebo (Normal Saline 0.9%)
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:Canada
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Recent Changes (Last 90 Days)

MEDIUMJun 16, 2026NCT07108894Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 16, 2026NCT07108894Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 16, 2026NCT07108894Status: RECRUITING → ACTIVE_NOT_RECRUITING

Frequently asked questions about ABCL575

What is ABCL575?

ABCL575 is an investigational monoclonal antibody being developed by AbCellera Biologics Inc. It is currently in Phase 1 clinical development for use in healthy volunteers. The drug is being studied in a first-in-human trial to evaluate its safety and tolerability.

Who makes ABCL575?

ABCL575 is being developed by AbCellera Biologics Inc., a biopharmaceutical company listed on the stock exchange under the ticker symbol ABCL. The company is conducting a Phase 1 clinical trial of this investigational monoclonal antibody in healthy volunteers.

What phase is ABCL575 in?

ABCL575 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The current Phase 1 trial is a first-in-human study designed to assess the drug's safety and tolerability.

What clinical trials is ABCL575 in?

ABCL575 is being studied in a Phase 1 clinical trial with the identifier NCT07108894. This is a first-in-human, single-ascending dose study conducted in healthy participants in Canada. The trial is randomized, double-blind, and placebo-controlled, with an enrollment of 40 participants aged 18 years and older.

Is ABCL575 being tested in healthy volunteers?

Yes, ABCL575 is being tested in healthy volunteers. The ongoing Phase 1 clinical trial, NCT07108894, is specifically designed to enroll healthy participants. The study is a single-ascending dose trial, meaning different groups of participants receive increasing doses of the drug to evaluate its safety and how it is processed by the body.