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SRK-439

Phase 1

Healthy | Small molecule | Other |Scholar Rock Holding Corporation|Last Updated: Mar 2, 2026

Target and mechanism

Molecular targetmyostatin
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment76

FDA Designations

No designations recorded

Clinical trial landscape

SRK-439 · 1 trial · 1 indication

Phase 1 1
NCT07444294A Single- and Multiple-Ascending Dose Study of SRK-439 in Healthy AdultsHealthy
RECRUITING76 Analytics
PHASE1RECRUITING
A Single- and Multiple-Ascending Dose Study of SRK-439 in Healthy Adults
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants
Up to 32 weeks

• Incidence of AEs

Secondary Endpoints

Evaluate the PK of single and multiple SRK-439 SC dose administration in healthy adult participants
Up to 32 weeks
Evaluate the PD of single and multiple SRK-439 SC dose administration in healthy adult participants
Up to 32 weeks
Evaluate the immunogenicity of single and multiple SRK-439 SC dose administration in healthy adult participants
Up to 32 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part AEXPERIMENTALParticipants will be treated with a single dose of SRK-439 or matching placebo.
Part BEXPERIMENTALParticipants will be treated with multiple doses of SRK-439 or matching placebo.

Interventions

NameTypeDescription
PlaceboDRUGMatching placebo to SRK-439, subcutaneous administration
SRK-439DRUGSingle ascending dose, subcutaneous administration
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: 1. Male or female participants, ≥18 to ≤55 years of age, at the time of informed consent 2. BMI of ≥18 kg/m2 to ≤35 kg/m2 (inclusive) at screening Exclusion Criteria: 1. Previous treatment with SRK-439 or apitegromab, or with other anti-myostatin therapies, including ACTR ...

Countries:United States
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Frequently asked questions about SRK-439

What is SRK-439?

SRK-439 is an investigational small molecule being developed by Scholar Rock Holding Corporation (ticker: SRRK). It is currently in Phase 1 clinical development for healthy adults. The drug targets myostatin, a protein involved in muscle regulation, and is being studied in a single- and multiple-ascending dose trial.

What does SRK-439 target?

SRK-439 targets myostatin, a protein that regulates muscle growth. By targeting myostatin, the drug is designed to potentially modulate muscle-related pathways. This mechanism is being evaluated in a Phase 1 study in healthy adults to assess safety and tolerability.

Who makes SRK-439?

SRK-439 is being developed by Scholar Rock Holding Corporation, a biopharmaceutical company traded under the ticker SRRK. The company is conducting a Phase 1 clinical trial of SRK-439 in healthy adults in the United States.

What phase is SRK-439 in?

SRK-439 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The ongoing Phase 1 study is a single- and multiple-ascending dose trial in healthy adults, currently recruiting participants.

What clinical trials is SRK-439 in?

SRK-439 is being studied in one Phase 1 clinical trial, identified as NCT07444294. This is a randomized, double-blind, controlled study titled 'A Single- and Multiple-Ascending Dose Study of SRK-439 in Healthy Adults.' The trial is recruiting 76 healthy participants aged 18 years and older in the United States.

Is SRK-439 the same as any other drug?

SRK-439 is not known to have alternative names. It is a distinct investigational small molecule developed by Scholar Rock. No other names for this drug have been reported in the available clinical trial information.