Recruiting
Phase 1

SRK-439

Sponsor:

Scholar Rock, Inc.

Code:

NCT07444294

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Placebo

SRK-439

SRK-439

Study Details

Brief summary:

A phase 1 study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SRK-439 in healthy adults

Conditions

Healthy

Study ID

NCT07444294

Start date

Nov 21, 2025

Status verified date

Feb, 2026

Completion date

Jun 9, 2027

Anticipated

Primary completion date

Dec 17, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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 antagonists.
2. History of immunosuppressive, chemotherapeutic, or radiation treatment within 12 months prior to screening.
3. Current or prior use of anabolic steroids, growth hormones, or other substances with known effects on muscle.
4. Use of therapies with potentially significant muscle effects (eg, insulin-like growth factor, systemic beta-agonist, neurotoxins, or muscle relaxants or muscle-enhancing supplements) in any form within 3 months prior to screening or during the study.
5. Any history of exposure to a mAb or Fc domain-bearing recombinant protein within 5 years prior to screening with any prior history of hypersensitivity reactions from exposure
6. Treatment with other investigational drugs or devices in a clinical study or exposure to a biologic therapeutic within 3 months or 5 half-lives, whichever is longer, prior to screening.

Study Design

Enrollment

76 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A

Participants will be treated with a single dose of SRK-439 or matching placebo.

experimental: Part B

Participants will be treated with multiple doses of SRK-439 or matching placebo.

Interventions

Placebo

Matching placebo to SRK-439, subcutaneous administration

SRK-439

Single ascending dose, subcutaneous administration

SRK-439

Multiple ascending dose, subcutaneous administration

Primary outcome measure

  • Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [ Time Frame: Up to 32 weeks ]
  • Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [ Time Frame: Up to 32 weeks ]
  • Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [ Time Frame: Up to 32 weeks ]
  • Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [ Time Frame: Up to 32 weeks ]
  • Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [ Time Frame: Up to 32 weeks ]
  • Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [ Time Frame: Up to 32 weeks ]
  • Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [ Time Frame: Up to 32 weeks ]
  • Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [ Time Frame: Up to 32 weeks ]
  • Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [ Time Frame: Up to 32 weeks ]
  • Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [ Time Frame: Up to 32 weeks ]
  • Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants [ Time Frame: Up to 32 weeks ]

Central Contacts and Locations

Central contacts

Scholar Rock, Inc. Clinical Trials Administration

857-259-3860MedicalInformation@scholarrock.com

Locations

Medpace CPU

Recruiting

Cincinnati, Ohio, United States, 45227

More Information

Sponsor

Scholar Rock, Inc.

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Scholar Rock, Inc. on 2026-03-02.