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ABCL635

Phase 1

Vasomotor Symptoms Associated With Menopause | Monoclonal antibody | Other |AbCellera Biologics Inc.|Last Updated: May 14, 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 Enrollment136
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07118891Study Evaluating ABCL635 for Vasomotor Symptoms of MenopausePHASE1 RECRUITING 136 — — Jun 23, 2025Feb 1, 2027May 14, 202613 Canada
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Study Endpoints
Primary Endpoints
Frequency and severity of adverse events (AE)
Day 0 to day 197
Number of participants with abnormalities in 12-lead safety electrocardiograms (ECG)
Day 0 to day 197
Number of participants with abnormalities in physical examination
Day 0 to day 197
Number of participants with abnormalities in laboratory parameters, including general biochemistry, hematology, endocrinology, and urinalysis
Day 0 to day 197
Secondary Endpoints
Mean change from baseline to each study week in the frequency of moderate and severe VMS (VMSM-S frequency)
up to day 141 (Part C)
Mean change from baseline to each study week in the severity of moderate and severe VMS (VMSM-S severity)
up to day 141 (Part C)
Mean change from baseline to each study week in the frequency of all reported VMS (VMSTotal frequency).
up to day 141 (Part C)
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ABCL635 Part AEXPERIMENTALPart A: healthy male and female participants will receive a single dose of ABCL635 administered by subcutaneous (SC) injection
Placebo Part APLACEBO_COMPARATORPart A: Healthy male and female participants will receive a single dose of placebo (dextrose 5% solution) administered by SC injection
ABCL635 Part BEXPERIMENTALPart B: healthy postmenopausal women with or without VMS will receive up to 3 doses of ABCL635 administered by SC injection
Placebo Part BPLACEBO_COMPARATORPart B: healthy postmenopausal women with or without VMS will receive up to 3 doses of placebo (dextrose 5% solution) administered by SC injection
ABCL635 Part CEXPERIMENTALPart C: postmenopausal women with moderate to severe VMS will receive a single dose of ABCL635 administered by SC injection
Placebo Part CPLACEBO_COMPARATORPart C: postmenopausal women with moderate to severe VMS will receive a single dose of placebo (dextrose 5% solution) administered by SC injection
ABCL635 Part C OLEEXPERIMENTALPart C open label extension (OLE): postmenopausal women with moderate to severe VMS will receive a single dose of ABCL635 administered by SC injection upon completion of 12-week assessment.
Interventions
NameTypeDescription
ABCL635BIOLOGICALParticipants will receive SC administrations of ABCL635
PlaceboBIOLOGICALParticipants will receive SC administration of placebo (5% dextrose solution)
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Eligibility Criteria
Age Range40 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites13

Inclusion Criteria: * Good general health as determined through a review of their medical history and after conducting a general physical examination * Body weight ≥ 45 to ≤ 120 kg * Body mass index (BMI) between 18.5 kg/m2 and 35.0 kg/m2 * Non- or ex-smoker (an ex-smoker is defined as someone who ...

Countries:Canada
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07118891primaryCompletionDate: changed
LOWMay 24, 2026NCT07118891studyFirstPostDate: changed