A Single- and Multiple-Ascending Dose Study of SRK-439 in Healthy Adults
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Healthy
In brief
A phase 1 study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SRK-439 in healthy adults
Key facts
- Study ID
- NCT07444294
- Run by
- Scholar Rock, Inc.
- People needed
- 76
- Starts
- 2025-11-21
- Expected to finish
- 2027-06-09
- Last updated by the study team
- 2026-03-02
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Previous treatment with SRK-439 or apitegromab, or with other anti-myostatin therapies, including ACTR antagonists.
- History of immunosuppressive, chemotherapeutic, or radiation treatment within 12 months prior to screening.
- Current or prior use of anabolic steroids, growth hormones, or other substances with known effects on muscle.
- 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.
- 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
- 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 it is running
- Medpace CPU — Cincinnati, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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