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SRK-439

Phase 1

Undisclosed | Small molecule | Other |Scholar Rock Holding Corporation|Trials Updated: Mar 2, 2026

SRK-439 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Mar 2026

SRK-439 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

SRK-439 clinical trials

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. It is in Phase 1 clinical development and is designed to target myostatin. The specific therapeutic indication for SRK-439 has not been disclosed.

What does SRK-439 target?

SRK-439 targets myostatin, a protein that regulates muscle growth. By binding to myostatin, SRK-439 is designed to inhibit its activity. This mechanism is being evaluated in a Phase 1 trial in healthy adult volunteers.

Who is developing SRK-439?

SRK-439 is being developed by Scholar Rock Holding Corporation, which trades on the Nasdaq under the ticker SRRK. The company is responsible for the clinical development of SRK-439.

What phase is SRK-439 in?

SRK-439 is in Phase 1 clinical development. It is not approved by the FDA and remains an investigational drug. The ongoing Phase 1 trial is evaluating the drug in healthy adult volunteers.

What clinical trials is SRK-439 in?

SRK-439 is being studied in a Phase 1 trial, NCT07444294, titled A Single- and Multiple-Ascending Dose Study of SRK-439 in Healthy Adults. The trial is currently recruiting and plans to enroll 76 participants in the United States.