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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Medpace CPU
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Study coordinator: Scholar Rock, Inc. Clinical Trials Administration
• Email: MedicalInformation@scholarrock.com
• Phone: 857-259-3860

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.