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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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Recent Changes (Last 90 Days)

LOWMay 26, 2026NCT07444294primaryCompletionDate: changed
LOWMay 24, 2026NCT07444294studyFirstPostDate: changed

Frequently asked questions about SRK-439

What is SRK-439 used for?

SRK-439 is an investigational small molecule being developed by Scholar Rock Holding Corporation (ticker: SRRK) for use in healthy adults. It is currently in Phase 1 clinical development, with a single trial studying its safety and tolerability in healthy volunteers.

What does SRK-439 target?

SRK-439 targets myostatin, a protein that regulates muscle growth. By targeting myostatin, SRK-439 is designed to potentially modulate muscle-related pathways, though its exact therapeutic application is still under investigation in early-stage clinical trials.

Who makes SRK-439?

SRK-439 is being developed by Scholar Rock Holding Corporation, a biopharmaceutical company traded on the stock exchange under the ticker symbol SRRK. The company is conducting a Phase 1 clinical trial to evaluate the drug's safety and pharmacokinetics in healthy adults.

What phase is SRK-439 in?

SRK-439 is in Phase 1 clinical development. It is currently being studied in a single- and multiple-ascending dose trial in healthy adults, which is actively recruiting participants. The drug is investigational and has not yet been approved by regulatory authorities.

What clinical trials is SRK-439 in?

SRK-439 is being evaluated in a Phase 1 clinical trial with the identifier NCT07444294. This study is a single- and multiple-ascending dose trial in healthy adults, enrolling 76 participants in the United States. The trial is randomized, double-blind, and controlled, and is currently recruiting.