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ABCL575

Phase 1

Healthy Volunteers | Monoclonal antibody | Other |AbCellera Biologics Inc.|Last Updated: Mar 23, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07108894A First-in-Human Phase 1 Single-Ascending Dose Study of ABCL575 in Healthy ParticipantsPHASE1 RECRUITING 40Jul 25, 2025Apr 1, 2027Mar 23, 20261 Canada
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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 — 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)
MEDIUMMay 26, 2026NCT07108894Phase: EARLY_PHASE1 → PHASE1
LOWMay 24, 2026NCT07108894studyFirstPostDate: changed