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CLYM116

Phase 1

Healthy Volunteers | Small molecule | Other |Climb Bio, Inc.|Last Updated: Feb 20, 2026

Target and mechanism

Molecular targetAPRIL
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

CLYM116 · 1 trial · 1 indication

Phase 1 1
NCT07248865A Phase 1 Study of CLYM116 in Normal Healthy VolunteersHealthy Volunteers
RECRUITING48 Analytics
PHASE1RECRUITING
A Phase 1 Study of CLYM116 in Normal Healthy Volunteers
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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 to 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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Frequently asked questions about CLYM116

What is CLYM116 used for?

CLYM116 is an investigational small molecule being studied for use in healthy volunteers. It is currently in a Phase 1 clinical trial to evaluate its safety, tolerability, and pharmacokinetics in normal healthy participants. The drug is not yet approved and remains in clinical development.

What does CLYM116 target?

CLYM116 targets APRIL, a protein involved in immune system regulation. By modulating APRIL activity, the drug may have potential therapeutic applications, though its specific intended indication has not been disclosed. The ongoing Phase 1 study focuses on healthy volunteers to assess the drug's basic properties.

Who makes CLYM116?

CLYM116 is being developed by Climb Bio, Inc., a biopharmaceutical company traded under the ticker symbol CLYM. The company is conducting a Phase 1 clinical trial of the drug in healthy volunteers in Australia.

What phase is CLYM116 in?

CLYM116 is in Phase 1 clinical development. The drug is currently being studied in a randomized, double-blind, placebo-controlled trial involving 48 healthy volunteers. This early-stage study is designed to evaluate the drug's safety and tolerability in humans.

What clinical trials is CLYM116 in?

CLYM116 is being evaluated in a Phase 1 study with the identifier NCT07248865, titled 'A Phase 1 Study of CLYM116 in Normal Healthy Volunteers.' The trial is actively recruiting participants in Australia and has an enrollment target of 48 healthy adults aged 18 years and older.