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CLYM116

Phase 1

Healthy Volunteers | Small molecule | Other |Climb Bio, Inc.|Last Updated: Feb 20, 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 Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07248865A Phase 1 Study of CLYM116 in Normal Healthy VolunteersPHASE1 RECRUITING 48 — — Dec 2, 2025Sep 1, 2026Feb 20, 20261 Australia
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Study Endpoints
Primary Endpoints
Safety and tolerability of single and multiple ascending doses of CLYM116 in healthy volunteers Incidence of treatment-emergent adverse events
From Screening through to Day 85, or final follow-up visit
Incidence of injection site reactions Number of injection site reactions
From Baseline through to Day 4 and Day 15 to Day 18
Secondary Endpoints
Maximum Observed Plasma Concentration (Cmax) Measurement of the maximum observed plasma concentration.
From Baseline through to Day 85 (except Day 14), or final follow-up visit
Time to Maximum Observed Concentration (Tmax) Measurement of the time to maximum observed concentration.
From Baseline through to Day 85 (except Day 14), or final follow-up visit
Area Under the Curve (AUC) Measurement of the area under the drug concentration-time curve.
From Baseline through to Day 85 (except Day 14), or final follow-up visit.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
CLYM116EXPERIMENTALSubcutaneous (SC) injection of CLYM116
PlaceboPLACEBO_COMPARATORSubcutaneous (SC) injection of placebo
Interventions
NameTypeDescription
CLYM116DRUGCLYM116 to be administered by SC injection
PlaceboDRUGPlacebo solution to be administered at a matching volume by SC injection
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy adult males and females aged 18-60 years, inclusive * Body mass index (BMI) between 18 and 32 kg/m² and weight between 45 and 110 kg * Clinically normal medical history, physical exam, ECG, and laboratory results (or abnormalities deemed not clinically significant) * W...

Countries:Australia
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07248865primaryCompletionDate: changed
LOWMay 24, 2026NCT07248865studyFirstPostDate: changed