Trying increasing single and repeated doses of SRK-439 in healthy adults

A Phase 1 Single- and Multiple-Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SRK-439 in Healthy Adults

This trial tests whether different single and repeated doses of SRK-439 are safe and how the body handles the drug in healthy adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Scholar Rock, Inc. (Industry-sponsored)
• Drugs / interventions: apitegromab, radiation
• Locations: 1 site (Cincinnati, Ohio)
• Trial ID: NCT07444294 on ClinicalTrials.gov

What this trial studies

This is a Phase 1, single- and multiple-ascending dose study in healthy adults that examines safety, tolerability, pharmacokinetics, and pharmacodynamics of SRK-439. Participants will receive either SRK-439 or placebo in sequential dosing cohorts with doses increasing between cohorts. Both single-dose and repeated-dose regimens are included to characterize short-term and repeat-exposure effects. Safety monitoring and blood sampling for PK/PD analyses will be performed throughout the dosing and follow-up periods.

Who should consider this trial

Good fit: Ideal candidates are healthy men or women aged 18 to 55 with a BMI of 18–35 kg/m2 who are not taking muscle-active drugs and have not previously received SRK-439 or other anti-myostatin therapies.

Not a fit: People seeking immediate treatment for a medical condition, those currently using anabolic steroids, growth hormones, or other muscle-altering therapies, or those with recent immunosuppressive or certain antibody exposures are unlikely to benefit.

Why it matters

Potential benefit: If successful, this work could speed development of SRK-439 and similar drugs that aim to protect or build muscle, potentially helping people with muscle-wasting conditions.

How similar studies have performed: Other anti-myostatin and related pathway agents have shown some promising biological signals in early trials, but results have varied and this specific compound remains early in clinical testing.

Eligibility criteria

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.

Where this trial is running

Cincinnati, Ohio

• Medpace CPU — Cincinnati, Ohio, United States (Recruiting)

Study contacts

• Study coordinator: Scholar Rock, Inc. Clinical Trials Administration

Conditions Healthy